Consulting Wallah › Device Explorer › Cardiovascular › Cardiac transseptal access set
Device Explorer · FDA GUDID · GMDN 47247

Cardiac transseptal access set

A collection of nonimplantable, invasive devices intended to be used to puncture the interatrial septum during a transseptal catheterization procedure, and to create a conduit for the introduction of various cardiovascular catheters into the left side of the h

US‑registered devices411in commercial distribution
Companies14labelers on GUDID
Single‑use100%of device records
Sterile96%labelled sterile
Prescription69%Rx‑only share
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Share of device records

Baylis Médicale Cie Inc8721%
Atraverse Medical, Inc6115%
Merit Medical5814%
Boston Scientific Corporation4912%
St. Jude Medical, Inc.4812%
Shanghai Microport Ep Medtech Co., Ltd.4611%
Merit Medical Systems, Inc.297%
Circa Scientific, Inc.102%

Top labelers

CompanyDevicesShare
Baylis Médicale Cie Inc8721%
Atraverse Medical, Inc6115%
Merit Medical5814%
Boston Scientific Corporation4912%
St. Jude Medical, Inc.4812%
Shanghai Microport Ep Medtech Co., Ltd.4611%
Merit Medical Systems, Inc.297%
Circa Scientific, Inc.102%
Synaptic Medical, Ltd.72%
Rhythm Xience, Inc.61%
Acutus Medical, Inc.41%
Cook Incorporated31%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TSP Crosser Transseptal Access SystemPathBuilder Steerable IntroducerPathBuilder Transseptal Guiding IntroducerNASwartz™Fast-Cath™HeartSpan®CardiaGuide™TSX™Dexterity Steerable IntroducerAcQGuide MiniAcQGuide FlexAcQGuide Mini-SGuider Catheter IntroducerFlextra Steerable IntroducerHOTWIRE™ RF GUIDEWIRE

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

FDA product codes

CodeNameDevices
DXFCatheter, Septostomy877
DYBIntroducer, Catheter792
DREDilator, Vessel, For Percutaneous Catheterization342
DQYCatheter, Percutaneous252
DYBINTRODUCER, CATHETER127
OFKPercutaneous atrial catheter kit43

GMDN & GCC registration

  • GMDN code 47247 · non‑implantable
  • Single‑use 100% · sterile 96% · Rx‑only 69% · 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) · 55Guidewire Diameter (Inch) · 51Guidewire Length (Centimeter) · 50Length (Centimeter) · 24Length (Millimeter) · 2Catheter Length (Centimeter) · 1

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

How many cardiac transseptal access set products are registered in the US?

411 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiac transseptal access set", from 14 companies. The largest labeler is Baylis Médicale Cie Inc with 21% of records.

Which FDA product codes apply?

DXF (Catheter, Septostomy), DYB (Introducer, Catheter), DRE (Dilator, Vessel, For Percutaneous Catheterization), 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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