Chrysalis Intelligence · Sponsors · Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc.

St.Paul, MN, US · 8 510(k) clearances · 24 PMAs · 3 recalls (1 Class I)

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Total clearances
8
2020-03-18 → 2022-03-01
Last 12 months
0
Product codes
3
Most recent
2022-03-01
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MCW Catheter, Peripheral, Atherectomy Class II Cardiovascular 3 2022-03-01
DQY — — — 3 2021-09-24
NTE — — — 2 2021-03-03
Class III

PMA approvals (24)

Total PMA records
24
Originals + supplements
Distinct product codes
1
First decision
2020-02-24
Most recent
2026-03-10
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-03-10 P130005-S051 Diamondback 360™ Coronary Orbital Atherectomy System; Diamondback 360 Precision™ Coronary Orbital Atherectomy System 30-Day Notice MCX Catheter, Coronary, Atherectomy Unknown
2026-02-26 P130005-S050 Diamondback 360™ Coronary Orbital Atherectomy System; Diamondback 360 Precision™ Coronary Orbital Atherectomy System 30-Day Notice MCX Catheter, Coronary, Atherectomy Unknown
2026-02-18 P130005-S049 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM 30-Day Notice MCX Catheter, Coronary, Atherectomy Unknown
2026-01-14 P130005-S048 Diamondback 360™ Coronary Orbital Atherectomy System; Diamondback 360 Precision™ Coronary Orbital Atherectomy System Special (Immediate Track) MCX Catheter, Coronary, Atherectomy Unknown
2025-06-03 P130005-S047 Diamondback 360 Coronary Orbital Atherectomy System; Diamondback 360 Precision Coronary Orbital Atherectomy System 30-Day Notice MCX Catheter, Coronary, Atherectomy Unknown
2025-04-24 P130005-S045 DIAMONDBACK 360® and Diamondback 360 Precision™ Coronary Orbital Atherectomy System (OAS) 30-Day Notice MCX Catheter, Coronary, Atherectomy Unknown
2025-04-14 P130005-S046 Diamondback 360™ Coronary Orbital Atherectomy System, Diamondback 360 Precision™ Coronary Orbital Atherectomy System 30-Day Notice MCX Catheter, Coronary, Atherectomy Unknown
2024-12-12 P130005-S044 Diamondback 360 Orbital Atherectomy and Diamondback 360 Precision Coronary Orbital Atherectomy System (OAS) 30-Day Notice MCX Catheter, Coronary, Atherectomy Unknown
2024-10-28 P130005-S043 DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS), DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System Real-Time Process MCX Catheter, Coronary, Atherectomy Unknown
2024-05-02 P130005-S042 DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (OAS) Normal 180 Day Track No User Fee MCX Catheter, Coronary, Atherectomy Unknown
2023-12-14 P130005-S040 DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (OAS) Real-Time Process MCX Catheter, Coronary, Atherectomy Unknown
2023-11-27 P130005-S041 DIAMONDBACK 360® Coronary Orbital Atherectomy System (OAS) 30-Day Notice MCX Catheter, Coronary, Atherectomy Unknown
2023-10-24 P130005-S039 DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS), DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System 30-Day Notice MCX Catheter, Coronary, Atherectomy Unknown
2023-09-07 P130005-S038 DIAMONDBACK 360 Coronary Orbital Atherectomy System, DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System 30-Day Notice MCX Catheter, Coronary, Atherectomy Unknown
2023-07-28 P130005-S037 DIAMONDBACK 360® and DIAMONDBACK 360 PRECISION ™ Coronary Orbital Atherectomy System (OAS) Real-Time Process MCX Catheter, Coronary, Atherectomy Unknown
2023-06-01 P130005-S036 Diamondback 360 Precision Coronary Orbital Atherectomy System Normal 180 Day Track MCX Catheter, Coronary, Atherectomy Unknown
2022-04-06 P130005-S034 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM Real-Time Process MCX Catheter, Coronary, Atherectomy Unknown
2022-03-11 P130005-S035 Diamondback 360 Coronary Orbital Atherectomy System 30-Day Notice MCX Catheter, Coronary, Atherectomy Unknown
2021-04-23 P130005-S033 DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) Real-Time Process MCX Catheter, Coronary, Atherectomy Unknown
2021-01-14 P130005-S032 DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) 30-Day Notice MCX Catheter, Coronary, Atherectomy Unknown
2020-12-10 P130005-S031 DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) Special (Immediate Track) MCX Catheter, Coronary, Atherectomy Unknown
2020-07-15 P130005-S030 Diamondback 360 Coronary Orbital Atherectomy System (OAS) 30-Day Notice MCX Catheter, Coronary, Atherectomy Unknown
2020-06-18 P130005-S029 DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) Normal 180 Day Track MCX Catheter, Coronary, Atherectomy Unknown
2020-02-24 P130005-S028 Diamondback 360 Coronary Orbital Atherectomy System (OAS) 30-Day Notice MCX Catheter, Coronary, Atherectomy Unknown
Safety

Recalls (3)

Class I (serious)
1
Risk of injury / death
Total recalls
3
Currently ongoing
0
Most recent
2021-11-22
DateSeverityStatusRecall # ProductCodeReason
2021-11-22 Class I Terminated Z-0394-2022 WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6 — Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withd…
2021-07-21 Class II Terminated Z-2386-2021 STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO — There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.
2021-07-21 Class II Terminated Z-2385-2021 DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145 — There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2022-03-01 K220109 DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System MCW Class II Cardiovascular
2021-09-24 K212725 ViperCross Support Catheters DQY — —
2021-09-14 K210586 Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system MCW Class II Cardiovascular
2021-08-26 K211240 ViperCross Support Catheters DQY — —
2021-05-26 K211251 ViperCath XC Peripheral Exchange Catheter DQY — —
2021-03-03 K210282 WIRION Embolic Protection System NTE — —
2020-11-19 K203008 DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System MCW Class II Cardiovascular
2020-03-18 K200198 WIRION NTE — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence