Consulting Wallah › Device Explorer › Catheters & tubes › Atherectomy laser system beam guide-catheter, peri
Device Explorer · FDA GUDID · GMDN 43229

Atherectomy laser system beam guide-catheter, peripheral

A sterile, flexible tube intended to be connected to an atherectomy laser system to invasively direct and deliver laser energy into the peripheral vasculature for the intraluminal photoablation or debulking of lesion material (blockages or total occlusions), t

US‑registered devices71in commercial distribution
Companies5labelers on GUDID
Single‑use97%of device records
Sterile97%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Spectranetics Corporation3448%
Eximo Medical Ltd1825%
North East Scientific Inc1623%
Philips Image Guided Therapy Corporation23%
Catheter Precision, Inc.11%

Top labelers

CompanyDevicesShare
Spectranetics Corporation3448%
Eximo Medical Ltd1825%
North East Scientific Inc1623%
Philips Image Guided Therapy Corporation23%
Catheter Precision, Inc.11%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AuryonAuryon Laser System 100-120 VacNES Reprocessed 1.4mm RX Turbo Elite Laser AtherNES Reprocessed 1.4mm OTW Turbo Elite Laser AtheNES Reprocessed 1.7mm RX Turbo Elite Laser AtherNES Reprocessed 1.7mm OTW Turbo Elite Laser AtheNES Reprocessed 2.0mm RX Turbo Elite Laser AtherNES Reprocessed 2.0mm OTW Turbo Elite Laser AtheNES Reprocessed 0.9mm RX Turbo Elite Laser AtherNES Reprocessed 0.9mm OTW Turbo Elite Laser AtheDABRA 101 CatheterTurbo-Power Laser Atherectomy CatheterTurbo-Power™Turbo-Elite Laser Atherectomy CatheterTurbo Tandem™Turbo Elite™

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, Atherectomy72
QTFReprocessed Atherectomy Catheter18
MCWCatheter, peripheral, atherectomy2
PDUCatheter For Crossing Total Occlusions1

GMDN & GCC registration

  • GMDN code 43229 · non‑implantable
  • Single‑use 97% · sterile 97% · Rx‑only 99% · 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

Outer Diameter (Millimeter) · 58Length (Centimeter) · 36Lumen/Inner Diameter (Inch) · 28Catheter Working Length (Centimeter) · 14Introducer Sheath Compatibility (French) · 8Guidewire Compatibility (French) · 4

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

How many atherectomy laser system beam guide-catheter, peripheral products are registered in the US?

71 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Atherectomy laser system beam guide-catheter, peripheral", from 5 companies. The largest labeler is Spectranetics Corporation with 48% of records.

Which FDA product codes apply?

MCW (Catheter, Peripheral, Atherectomy), QTF (Reprocessed Atherectomy Catheter), MCW (Catheter, peripheral, atherectomy), PDU (Catheter For Crossing Total Occlusions)

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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