510(k) K061424 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
CELSITE/ CELSITE CONCEPT, ACCESS PORTS
| Applicant | Aesculap, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, Jul 31, 2006 |
| Received | May 23, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061424
| 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 |
| Sep 3, 2009 | B. Braun Interventional Systems Celsite Access Port Model ST305P.
The Celsite Access Port model ST305P is a member of the Celsite product line of implantable port and catheter systems. Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.