Consulting Wallah › Device Explorer › Catheters & tubes › Mechanical atherectomy system catheter, peripheral
Device Explorer · FDA GUDID · GMDN 44307

Mechanical atherectomy system catheter, peripheral

A sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma i

US‑registered devices178in commercial distribution
Companies9labelers on GUDID
Single‑use99%of device records
Sterile99%labelled sterile
Prescription94%Rx‑only share
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Share of device records

Cardiovascular Systems, Inc.6637%
Covidien Lp4022%
Volcano Atheromed, Inc.1810%
Medtronic, Inc.1810%
Philips Image Guided Therapy Corporation148%
Rex Medical, Inc.84%
Avinger, Inc.74%
Boston Scientific Corporation42%

Top labelers

CompanyDevicesShare
Cardiovascular Systems, Inc.6637%
Covidien Lp4022%
Volcano Atheromed, Inc.1810%
Medtronic, Inc.1810%
Philips Image Guided Therapy Corporation148%
Rex Medical, Inc.84%
Avinger, Inc.74%
Boston Scientific Corporation42%
Cardio Flow, Inc.32%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Revolution Peripheral Atherectomy SystemPantheris LVLightbox L3Ocelot PIXLKittykat IIWildcatFreedomFlow Orbital Circumferential Atherectomy Phoenix 2.4mm x 130cm 7F Pre-Deflected AtherectoPhoenix 2.2mm x 130cm 6F Pre-Deflected AtherectoPhoenix 2.2mm x 149cm 6F Atherectomy SystemPhoenix 2.2mm x 130cm 6F Atherectomy SystemPhoenix 1.8mm x 149cm 5F Atherectomy SystemPhoenix 1.8mm x 130cm 5F Atherectomy SystemPhoenix 1.5mm x 149cm 4F Atherectomy SystemPhoenix 2.4mm x 130cm 7F Pre-Deflected AtherectoPhoenix 2.2mm x 130cm 6F Pre-Deflected Atherecto

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MCWCatheter, Peripheral, Atherectomy114
MCWCatheter, peripheral, atherectomy73
NQQSystem, Imaging, Optical Coherence Tomography (Oct)4
DQYCatheter, Percutaneous4
PDUCatheter For Crossing Total Occlusions1

GMDN & GCC registration

  • GMDN code 44307 · non‑implantable
  • Single‑use 99% · sterile 99% · Rx‑only 94% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Centimeter) · 72Outer Diameter (Millimeter) · 68Catheter Gauge (French) · 38Balloon Diameter (Millimeter) · 4Atherectomy Rotating Component Diameter (Millimeter) · 3Balloon Catheter Tip Length (Centimeter) · 2

Use these as the dimensions to specify in a tender line.

How many mechanical atherectomy system catheter, peripheral products are registered in the US?

178 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Mechanical atherectomy system catheter, peripheral", from 9 companies. The largest labeler is Cardiovascular Systems, Inc. with 37% of records.

Which FDA product codes apply?

MCW (Catheter, Peripheral, Atherectomy), MCW (Catheter, peripheral, atherectomy), NQQ (System, Imaging, Optical Coherence Tomography (Oct)), DQY (Catheter, Percutaneous)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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