510(k) K943770 ยท FPA Set, Administration, Intravascular
LOW VOLUME MULTIPORT
| Applicant | B. Braun of America, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Apr 10, 1995 |
| Received | Aug 2, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943770
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2025 | B Braun Medical Inc Anesthesia IV 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 the fo 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 Extension 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 the follow Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc Extension 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 the follow Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc Extension 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 the follow Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc IV 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 th Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc IV 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 th Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc IV 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 th Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc IV 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 th Open, Classified |
FPA | None listed |
| Sep 13, 2024 | B. Braun Medical, Inc. AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036 Open, Classified |
FPA | None listed |
| Jun 12, 2003 | Braun,B Medical Inc Gravity and Infusion Pump Intravenous (IV) Sets using the Y-site Ultrasite Valve including: Horizon Pump IV Sets; Vista Pump IV Sets; Primary IV Sets; Blood Sets; Burette Sets; Filtered Administration Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.