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Device Explorer · FDA GUDID · GMDN 61205

Mechanical atherectomy system, coronary, line-powered

An assembly of devices intended to mechanically disrupt/remove atheroma plaque from the walls of coronary arteries. It typically includes a mains electricity (AC-powered) energy-producing generator with monitoring functions, a remote control or foot-switch, a

US‑registered devices69in commercial distribution
Companies2labelers on GUDID
Single‑use90%of device records
Sterile90%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Boston Scientific Corporation5986%
Cardiovascular Systems, Inc.1014%

Top labelers

CompanyDevicesShare
Boston Scientific Corporation5986%
Cardiovascular Systems, Inc.1014%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Peripheral ROTAPRO™Rotaglide™Diamondback CoronaryDiamondback CoroanryROTAPRO™ROTAPRO™ AdvancerPeripheral RotaLink® PlusRotablator™ Rotational Atherectomy System ConsolRotablator™RotaLink™ AdvancerRotaLink™ PlusRotaLink™ Burr

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

FDA product codes

CodeNameDevices
MCXCATHETER, CORONARY, ATHERECTOMY43
MCWCatheter, peripheral, atherectomy21
MCXCatheter, Coronary, Atherectomy10

GMDN & GCC registration

  • GMDN code 61205 · non‑implantable
  • Single‑use 90% · sterile 90% · Rx‑only 100% · 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

Atherectomy Rotating Component Diameter (Millimeter) · 8Guidewire Diameter (Millimeter) · 8Outer Diameter (Millimeter) · 8Shaft Length (Centimeter) · 1

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

How many mechanical atherectomy system, coronary, line-powered products are registered in the US?

69 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Mechanical atherectomy system, coronary, line-powered", from 2 companies. The largest labeler is Boston Scientific Corporation with 86% of records.

Which FDA product codes apply?

MCX (CATHETER, CORONARY, ATHERECTOMY), MCW (Catheter, peripheral, atherectomy), MCX (Catheter, Coronary, Atherectomy)

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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