Chrysalis Intelligence · Product Codes · LIT

LIT · Catheter, Angioplasty, Peripheral, Transluminal

Cardiovascular · 38 clearances · 24 unique sponsors

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Device class
Class II
Regulation 870.1250
Total clearances
38
2020-01-15 → 2026-05-20
Last 12 months
3
Unique sponsors
24
Classification details
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.1250
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Biotronik, Inc. 4 0 2025-04-04
Cordis Corporation 3 0 2021-04-23
Natec Medical , Ltd. 3 1 2025-12-18
OrbusNeich Medical (Shenzhen) Co., Ltd. 3 0 2024-06-11
Brosmed Medical Co., Ltd. 2 0 2025-02-27
Summa Therapeutics, LLC 2 0 2024-07-16
Kossel Medtech (Suzhou) Co., Ltd. 2 0 2023-12-20
Boston Scientific Corporation 2 0 2024-07-10
Creagh Medical, Ltd. 2 0 2023-03-22
Nexstep Medical 1 0 2020-01-15
Abbott Vascular 1 0 2022-05-05
Qualimed USA, LLC 1 0 2021-08-03
WAVE Medical AG 1 1 2026-05-20
Infinity Angioplasty Balloon Company, LLC 1 0 2020-05-20
Creagh Medical Ltd. Dba Surmodics, Inc. 1 0 2024-11-15
Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) 1 0 2020-11-18
Dk Medical Technology Co., Ltd. 1 0 2023-04-05
Cordis US Corp 1 0 2022-08-22
ABBOTT MEDICAL 1 1 2026-02-13
C.R. Bard, Inc. 1 0 2023-01-20
Contego Medical, Inc. 1 0 2022-06-09
Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, 1 0 2021-06-16
Silk Road Medical, Inc. 1 0 2022-09-02
Medtronic, Inc. 1 0 2021-12-15
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
37220 CPT — High CPT code for percutaneous angioplasty of peripheral vessels with imaging guidance
37223 CPT — Medium Alternative CPT for peripheral transluminal angioplasty with stent
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-20 K260304 WAVE Medical AG WAVE PTA Balloon Catheter
2026-02-13 K252512 ABBOTT MEDICAL Armada™ 14 NC PTA Catheter
2025-12-18 K251915 Natec Medical , Ltd. Amethyst HP PTA OTW 0.035 Catheter
2025-04-04 K250706 Biotronik, Inc. Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
2025-02-27 K243704 Brosmed Medical Co., Ltd. Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
2024-12-18 K241040 Natec Medical , Ltd. Amethyst HP PTA OTW 0.035 Catheter
2024-11-15 K242419 Creagh Medical Ltd. Dba Surmodics, Inc. 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
2024-07-16 K241740 Summa Therapeutics Finesse Injectable™ PTA Balloon Dilatation Catheter
2024-07-11 K241711 Biotronik, Inc. Oscar Peripheral Multifunctional Catheter system
2024-07-10 K241683 Boston Scientific Corporation Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031406020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031408020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031410020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031412020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031415020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H749390314
2024-06-11 K241025 OrbusNeich Medical (Shenzhen) Co., Ltd. JADE PLUS PTA Balloon Dilatation Catheter
2023-12-20 K231402 Kossel Medtech (Suzhou) Co., Ltd. HP PTA Balloon Dilatation Catheter
2023-05-26 K230263 Summa Therapeutics, LLC Finesse™ Injectable PTA Balloon Dilatation Catheter
2023-04-05 K214009 Dk Medical Technology Co., Ltd. D·Kaptain PTA High Pressure Balloon Dilatation Catheter
2023-03-22 K230191 Creagh Medical, Ltd. Arise™ UHP Dilatation Catheter
2023-02-16 K222065 Biotronik, Inc. Passeo-35 Xeo Peripheral Dilatation Catheter
2023-01-20 K223177 C.R. Bard, Inc. Highlander™ 014 PTA Balloon Dilatation Catheter
2022-12-14 K221245 Kossel Medtech (Suzhou) Co., Ltd. PTA Balloon Dilatation Catheter
2022-09-02 K221414 Silk Road Medical, Inc. ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
2022-08-22 K221832 Cordis US Corp SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter
2022-07-19 K212215 Brosmed Medical Co., Ltd. Tiche PTA Balloon Dilatation Catheter
2022-07-06 K214038 Biotronik, Inc. Oscar Peripheral Multifunctional Catheter system
2022-06-29 K220410 Natec Medical , Ltd. Ebony HP PTA OTW 0.035 Catheter
2022-06-09 K221339 Contego Medical, Inc. Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection
2022-05-05 K221057 Abbott Vascular Viatrac 14 Plus Peripheral Dilatation Catheter
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence