510(k) K911355 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015
| Applicant | Strato Medical Corp., Beverly MA, US |
| Decision | Substantially Equivalent, Apr 15, 1991 |
| Received | Feb 21, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911355
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2010 | Angiodynamics, INC LifePort, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816. Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.