510(k) K962230 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
CELSITE PORT WITH PRECONNECTED CATHETER
| Applicant | B.Braun Medical, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Dec 16, 1996 |
| Received | Jun 10, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962230
| 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.