510(k) K130576 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
CELSITE IMPLANTABLE ACCESS PORT SYSTEMS
| Applicant | B. Braun Interventional Systems, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Apr 2, 2013 |
| Received | Mar 5, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130576
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 5, 2025 | B.Braun Medical S.A.S. 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 Open, Classified |
LJT | None listed |
| Aug 13, 2015 | B. Braun Interventional Systems Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to t Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.