Consulting Wallah › Device Explorer › Catheters & tubes › Intra-aortic balloon catheter
Device Explorer · FDA GUDID · GMDN 34919

Intra-aortic balloon catheter

A flexible, balloon-tipped, tube that is placed in the aorta distal to the aortic valve to augment the heart's pumping capability. It is typically introduced percutaneously via one of the femoral arteries and advanced to the descending thoracic aorta using flu

US‑registered devices168in commercial distribution
Companies3labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Datascope Corp.9557%
Teleflex Incorporated7042%
Insightra Medical, Inc.32%

Top labelers

CompanyDevicesShare
Datascope Corp.9557%
Teleflex Incorporated7042%
Insightra Medical, Inc.32%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Ultra IABP Catheter KitARROWMega 8Fr 50cc IAB with Accessories (APA) (TurkeyMega 8Fr 50cc IAB with Accessories (Turkey)Mega 7.5Fr 40cc IAB with Accessories (APA) (TurkMega 7.5Fr 40cc IAB with Accessories (Turkey)Mega 7.5Fr 30cc IAB with Accessories (APA) (TurkMega 7.5Fr 30cc IAB with Accessories (Turkey)Linear 7.5Fr 25cc IAB with Accessories (APA) (TuLinear 7.5Fr 25cc IAB with Accessories (Turkey)Linear 7.5Fr 40cc IAB with Accessories (Turkey)Linear 7.5Fr 34cc IAB with Accessories (Turkey)Sensation Plus 8Fr 50cc IAB with Accessories (TuSensation Plus 7.5Fr 40cc IAB with Accessories (Linear 7.5Fr 40cc IAB with Accessories (APA) (TuLinear 7.5Fr 34cc IAB with Accessories (APA) (Tu

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

FDA product codes

CodeNameDevices
DSPSystem, Balloon, Intra-Aortic And Control98
DSPSystem, balloon, intra-aortic and control70

GMDN & GCC registration

  • GMDN code 34919 · non‑implantable
  • Single‑use 100% · sterile 100% · 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

Catheter Gauge (French) · 111Total Volume (Milliliter) · 21Length (Inch) · 5Length (Centimeter) · 1Outer Diameter (Inch) · 1

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

No closely related category with 50+ devices.

How many intra-aortic balloon catheter products are registered in the US?

168 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intra-aortic balloon catheter", from 3 companies. The largest labeler is Datascope Corp. with 57% of records.

Which FDA product codes apply?

DSP (System, Balloon, Intra-Aortic And Control), DSP (System, balloon, intra-aortic and control)

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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