Data / Medical devices / France / B. Braun Medical
B. Braun Medical: FDA-registered device maker in CHASSENEUIL-DU-POITOU Vienne, France, 4 510(k) clearances
B. Braun Medical is registered with the FDA (registration 9612452) in CHASSENEUIL-DU-POITOU Vienne, France. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 31, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9612452
- FEI number
- 3002806713
- Address
- 30 Avenue Des Temps Modernes, CHASSENEUIL-DU-POITOU Vienne, France, 86360
- Owner or operator
- B. BRAUN MEDICAL SAS (8023036)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 20, 2009
- Registered through
- 2026
- Brand names listed
- Celsite, Celsite Babyport, Celsite Babyport S, Surecan Safety II, VenaTech Convertible Vena Cava Filter System, VenaTech LP Vena Cava Filter System, Venatech LP Brachial Introducer System (Antecubital)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filter, Intravascular, Cardiovascular | DTK | 2 | Manufacturer | accessdata.fda.gov |
| Non-Coring (Huber) Needle | PTI | 2 | Specification developer | accessdata.fda.gov |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 31, 2024 | K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System | DTK | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| November 3, 2017 | K170897 | Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site | PTI | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| April 2, 2013 | K130576 | CELSITE IMPLANTABLE ACCESS PORT SYSTEMS | LJT | Substantially Equivalent | B. Braun Interventional Systems, Inc. | accessdata.fda.gov |
| January 12, 2007 | K063217 | VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL) | DTK | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 21, 2025 | 97407 | Class II | Ongoing | Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A | The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall. | accessdata.fda.gov |
Compare with other makers
- All makers of Filter, Intravascular, Cardiovascular
- All makers of Port & Catheter, Implanted, Subcutaneous, Intravascular
- All makers of Non-Coring (Huber) Needle
Updated September 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.