510(k) K871153 ยท DYB Introducer, Catheter
CATHETER INTRODUCER
| Applicant | Angeion Corp., Plymouth MN, US |
| Decision | Substantially Equivalent, Jun 24, 1987 |
| Received | Mar 24, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871153
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2006 | Oscor Inc. Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)'' Catalog # 06607 (Oscor) and 666089-201 (Guidant) Terminated |
DYB | None listed |
| 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.