510(k) K952435 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
CELSITE PEDIATRIC VENOUS SYSTEM
| Applicant | B.Braun Medical, Inc., Melsungen, DE |
| Decision | Substantially Equivalent, Apr 17, 1996 |
| Received | May 24, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952435
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.