510(k) K953529 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM
| Applicant | Strato/Infusaid, Inc., Norwood MA, US |
| Decision | Substantially Equivalent, Jan 26, 1996 |
| Received | Jul 27, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953529
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 24, 2004 | Horizon Medical Products Inc LifePort, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.