Chrysalis Intelligence · Product Codes · MCW

MCW · Catheter, Peripheral, Atherectomy

Cardiovascular · 25 clearances · 12 unique sponsors

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Device class
Class II
Regulation 870.4875
Total clearances
25
2020-11-19 → 2026-04-10
Last 12 months
1
Unique sponsors
12
Classification details
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.4875
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
Eximo Medical, Ltd. 7 1 2026-04-10
Cardio Flow Inc., 4 0 2025-04-25
Cardiovascular Systems, Inc. 3 0 2022-03-01
Avinger, Inc. 2 0 2023-06-06
Spectranetics 2 0 2025-03-13
Volcano Atheromed, Inc. 1 0 2021-06-14
Boston Scientific Corporation 1 0 2022-09-06
Medtronic, Inc. 1 0 2021-08-24
C.R. Bard, Inc. 1 0 2021-09-14
Rex Medical, L.P. 1 0 2021-12-15
Cardiovascualr Systems, Inc. 1 0 2022-04-27
Bard Peripheral Vascular, Inc. 1 0 2025-01-30
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
35701 CPT — Medium CPT for atherectomy of peripheral vessels; directional or rotational atherectomy catheter procedure code
37229 CPT — Medium CPT for mechanically atherectomy; alternate atherectomy code depending on vessel and approach
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-10 K260244 Eximo Medical Auryon Atherectomy System
2025-04-25 K250723 Cardio Flow Inc., FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
2025-03-13 K250385 Spectranetics Turbo-Elite Laser Atherectomy Catheter
2025-01-30 K242757 Bard Peripheral Vascular, Inc. Rotarex Atherectomy System
2024-11-05 K242947 Cardio Flow Inc., FreedomFlow™ Orbital Circumferential Atherectomy System
2024-06-27 K241553 Eximo Medical, Ltd. Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
2024-02-15 K233483 Cardio Flow Inc., FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
2023-12-15 K233668 Eximo Medical, Ltd. Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)
2023-09-27 K231538 Cardio Flow Inc., FreedomFlow Orbital Circumferential Atherectomy System
2023-06-09 K230709 Eximo Medical, Ltd. Auryon Atherectomy System
2023-06-06 K230005 Avinger, Inc. Pantheris LV Atherectomy Catheter
2022-12-08 K222837 Spectranetics, Inc. Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
2022-09-26 K220116 Eximo Medical, Ltd. Auryon Atherectomy Catheters
2022-09-06 K220962 Boston Scientific Corporation ROTAPRO Rotational Atherectomy System
2022-06-09 K221077 Eximo Medical, Ltd. Auryon Atherectomy System
2022-04-27 K220568 Cardiovascualr Systems, Inc. Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
2022-03-01 K220109 Cardiovascular Systems, Inc. DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
2021-12-15 K212351 Rex Medical, L.P. Revolution Peripheral Atherectomy System
2021-11-16 K212047 Avinger, Inc. Pantheris System
2021-09-14 K211738 C.R. Bard, Inc. Rotarex Atherectomy System
2021-09-14 K210586 Cardiovascular Systems, Inc. Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system
2021-08-24 K212027 Medtronic, Inc. TurboHawk Plus Directional Atherectomy System
2021-06-14 K211518 Volcano Atheromed, Inc. 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System
2020-12-02 K202835 Eximo Medical, Ltd. Auryon Atherectomy System
2020-11-19 K203008 Cardiovascular Systems, Inc. DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence