510(k) K964929 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
PERIPHERALLY INSERTED CENTRAL CATHETER
| Applicant | B.Braun Medical, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Jun 2, 1997 |
| Received | Dec 9, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964929
| 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 |
| Jan 10, 2004 | Abbott Laboratories HPD/ADD/GPRD CA 125 Controls, list 9C22-10; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LTK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.