A device designed to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access typically to facilitate fluid aspiration and injection/infusion, blood sampling, and pressure monitoring. It is typically a long, thin
| Company | Devices | Share |
|---|---|---|
| Ppmdm | 33 | 29% |
| Merit Medical | 29 | 25% |
| Merit Medical Systems, Inc. | 25 | 22% |
| St. Jude Medical Cardiovascular Division | 12 | 10% |
| Shanghai Microport Ep Medtech Co., Ltd. | 8 | 7% |
| St. Jude Medical, Inc. | 4 | 3% |
| Medtronic, Inc. | 2 | 2% |
| Indian Wells Medical, Inc. | 2 | 2% |
Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| DRC | Trocar | 106 |
| DXF | Catheter, Septostomy | 8 |
| DYB | INTRODUCER, CATHETER | 4 |
| OEZ | Cardiovascular procedure kit | 3 |
Use these as the dimensions to specify in a tender line.
115 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiac transseptal needle, single-use", from 8 companies. The largest labeler is Ppmdm with 29% of records.
DRC (Trocar), DXF (Catheter, Septostomy), DYB (INTRODUCER, CATHETER), OEZ (Cardiovascular procedure kit)
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.