510(k) K840212 ยท FPA Set, Administration, Intravascular
CONCENTRATED PLATELET ADMIN. SET
| Applicant | American Mcgaw, Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 6, 1984 |
| Received | Jan 19, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K840212
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2025 | B Braun Medical Inc Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as Open, Classified |
FPA | None listed |
| Nov 20, 2019 | B. Braun Medical, Inc. Y-Type Blood Set, Catalog Number 490293 Terminated |
FPA | None listed |
| Nov 20, 2019 | B. Braun Medical, Inc. Y-Type Blood Set, Catalog Number 490314 Terminated |
FPA | None listed |
| Nov 20, 2019 | B. Braun Medical, Inc. Y-Type Blood Set, Catalog Number 490425 Terminated |
FPA | None listed |
| Nov 20, 2019 | B. Braun Medical, Inc. Safeline Y-Type Blood Set, Catalog Number NF5140 Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.