510(k) K213085 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Introcan Safety 3 Closed IV Catheter
| Applicant | B.Braun Medical, Inc., Allentown PA, US |
| Decision | Substantially Equivalent, Oct 25, 2021 |
| Received | Sep 24, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213085
| 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.