510(k) K993024 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
CELSITE IMPLANTABLE PORT WITH VALVED CATHETER
| Applicant | B. Braun of America, Inc., Allentown PA, US |
| Decision | Substantially Equivalent, Mar 13, 2000 |
| Received | Sep 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993024
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2011 | B. Braun Interventional Systems B. Braun Celsite Venous Access Ports , Distributed by Aesculpa Inc.
Model ST301, ST305V, ST301G, ST501G and ST315
Reference # Model #
04430425 ST301
04430095 Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.