510(k) K894446 ยท DYB Introducer, Catheter
ANGEION HEMOSTASIS VALVE INTRODUCER
| Applicant | Angeion Corp., Plymouth MN, US |
| Decision | Substantially Equivalent, Nov 30, 1989 |
| Received | Jul 17, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894446
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2005 | B. Braun Medical, Inc. Locking Tear-Away Sheath Introducer Product Line.
ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/;
P560K PICC 5FR W/INTRO KIT;
MTI451845 4.5FR MINI T/A;
MTI551845 5.5FR MINI TA;
MTI651845 6.5FR MINI T/A;
P Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.