510(k) K955407 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS
| Applicant | Sims Deltec, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Feb 12, 1996 |
| Received | Nov 27, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955407
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2013 | Smiths Medical ASD, Inc. Smiths Medical, Deltec:
REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System.
REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System.
Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.