510(k) K111236 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1
| Applicant | B.Braun Melsungen AG, Allentown PA, US |
| Decision | Substantially Equivalent, Aug 30, 2011 |
| Received | May 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111236
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2025 | B Braun Medical Inc Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter. Open, Classified |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.