510(k) K001633 ยท MSD Catheter, Hemodialysis, Implanted
LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000
| Applicant | Vasca, Inc., Tewksburt MA, US |
| Decision | Substantially Equivalent, Aug 24, 2000 |
| Received | May 26, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001633
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2003 | Vasca, Inc. LifeSite Hemodialysis Cannula Exchange Kit
Part Number: LHCEK0000 Terminated |
MSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.