Chrysalis Intelligence · Sponsors · Spectranetics, Inc.

Spectranetics, Inc.

Colorado Springs, CO, US · 6 510(k) clearances · 25 PMAs · 6 recalls (1 Class I)

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Total clearances
6
2020-12-23 → 2025-03-13
Last 12 months
0
Product codes
4
Most recent
2025-03-13
Name variants in FDA filings: Spectranetics / Spectranetics, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MCW Catheter, Peripheral, Atherectomy Class II Cardiovascular 2 2025-03-13
DRE Dilator, Vessel, For Percutaneous Catheterization Class II Cardiovascular 2 2022-12-15
QRJ Laser-Powered Inferior Vena Cava Filter Retrieval Catheter Class II Cardiovascular 1 2021-12-21
MJN — — — 1 2020-12-23
Class III

PMA approvals (25)

Total PMA records
25
Originals + supplements
Distinct product codes
2
First decision
2020-09-11
Most recent
2026-08-14
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-08-14 P910001-S126 ELCA Coronary Laser Atherectomy Catheters 135 Review Track For 30-Day Notice LPC Device, Angioplasty, Laser, Coronary Unknown
2026-02-06 P910001-S124 ELCA Coronary Atherectomy Catheters 135 Review Track For 30-Day Notice LPC Device, Angioplasty, Laser, Coronary Unknown
2025-12-18 P910001-S125 ELCA Coronary Atherectomy Catheters 30-Day Notice LPC Device, Angioplasty, Laser, Coronary Unknown
2025-04-04 P050018-S035 AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating 135 Review Track For 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2025-01-15 P050018-S036 AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2024-11-21 P910001-S123 Philips Laser System Real-Time Process LPC Device, Angioplasty, Laser, Coronary Unknown
2024-09-05 P910001-S122 ELCA Coronary Angioplasty Laser Sheaths, Philips Laser System (CVX/PLS) 30-Day Notice LPC Device, Angioplasty, Laser, Coronary Unknown
2024-02-14 P050018-S034 AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating Normal 180 Day Track No User Fee NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2023-10-30 P910001-S121 Philips Laser System Real-Time Process LPC Device, Angioplasty, Laser, Coronary Unknown
2023-10-19 P050018-S033 AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2023-08-31 P910001-S120 Philips Laser System Real-Time Process LPC Device, Angioplasty, Laser, Coronary Unknown
2023-07-07 P050018-S032 AngioSculpt RX PTCA Scoring Balloon Catheter, AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2023-05-04 P910001-S119 ECLA Coronary Atherectomy Catheters 30-Day Notice LPC Device, Angioplasty, Laser, Coronary Unknown
2023-03-21 P910001-S118 ELCA Coronary Atherectomy Catheters 30-Day Notice LPC Device, Angioplasty, Laser, Coronary Unknown
2022-10-21 P910001-S117 ELCA Coronary Laser Catheters 30-Day Notice LPC Device, Angioplasty, Laser, Coronary Unknown
2022-08-19 P910001-S116 ELCA Coronoary Laser Atherectomy Catheter Real-Time Process LPC Device, Angioplasty, Laser, Coronary Unknown
2022-05-05 P910001-S115 Philips Laser System Real-Time Process LPC Device, Angioplasty, Laser, Coronary Unknown
2022-02-24 P910001-S114 ELCA Coronary Atherectomy Catheters Special (Immediate Track) LPC Device, Angioplasty, Laser, Coronary Unknown
2021-12-23 P050018-S030 AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (AngioSculpt Evo catheter) 135 Review Track For 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2021-09-02 P910001-S112 Spectranetics Laser Sheath (SLS) Normal 180 Day Track LPC Device, Angioplasty, Laser, Coronary Unknown
2021-07-27 P050018-S031 AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2021-05-11 P910001-S113 ELCA Coronary Atherectomy Catheter Real-Time Process LPC Device, Angioplasty, Laser, Coronary Unknown
2020-12-22 P910001-S111 Spectranetics CVX-300 Excimer Laser System Real-Time Process LPC Device, Angioplasty, Laser, Coronary Unknown
2020-09-21 P050018-S028 AngioSculpt PTCA Scoring Balloon Catheter, AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2020-09-11 P050018-S026 AngioSculpt PTCA Scoring Balloon Catheter, Rapid Exchange (RX) Normal 180 Day Track NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
Safety

Recalls (6)

Class I (serious)
1
Risk of injury / death
Total recalls
6
Currently ongoing
5
Most recent
2025-01-10
DateSeverityStatusRecall # ProductCodeReason
2025-01-10 Class I Ongoing Z-1070-2025 Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,… — Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, co…
2024-11-25 Class II Ongoing Z-0680-2025 Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 m… — Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.
2023-11-15 Class II Ongoing Z-0509-2024 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy C… — Incorrect product labeling. Exterior product box label does not match internal pouch label.
2022-10-14 Class II Ongoing Z-0221-2023 Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular syst… — Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proc…
2022-06-01 Class II Ongoing Z-1351-2022 Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60H… — The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until cod…
2020-03-31 Class II Terminated Z-2143-2020 Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length… — There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extr…
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2025-03-13 K250385 Turbo-Elite Laser Atherectomy Catheter MCW Class II Cardiovascular
2022-12-15 K223472 TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) DRE Class II Cardiovascular
2022-12-08 K222837 Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters MCW Class II Cardiovascular
2022-08-24 K212784 TightRail Guardian Motorized Dilator Sheath DRE Class II Cardiovascular
2021-12-21 DEN210024 CavaClear Laser Sheath QRJ Class II Cardiovascular
2020-12-23 K203540 Bridge Occlusion Balloon MJN — —
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence