510(k) K020785 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
INTROCAN SAFETY IV CATHETER
| Applicant | B.Braun Medical, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Aug 28, 2002 |
| Received | Mar 11, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020785
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2022 | B Braun Medical Inc Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access. Open, Classified |
FOZ | None listed |
| Jul 20, 2004 | Braun,B Medical Inc Introcan Safety IV Catheter 22G x 1'' PUR with Wings. The affected catalogs and lot numbers:
Catalog Number 4253540 - Lot number 3G26258U02
Catalog Number 4253540 - Lot number 3G27258U02 Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.