510(k) K990705 ยท DYB Introducer, Catheter
MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET
| Applicant | Medamicus, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jun 28, 1999 |
| Received | Mar 4, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990705
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2014 | Greatbatch Medical Coaxial Micro-Introducer Kit.
Greatbatch Part Number/Bard Access Systems Order Number/Part Description
10636-001
8004011
Kit Coax 10 Pack 4FR Bard
10636-002
8005011
Kit Coax 10 Pack 5FR Bard
1063 Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.