510(k) K172831 · FRN Pump, Infusion
Perfusor® Space Syringe Infusion Pump System
| Applicant | B.Braun Medical, Inc., Allentown PA, US |
| Decision | Substantially Equivalent, Jun 12, 2018 |
| Received | Sep 18, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172831
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2024 | B Braun Medical Inc Brand Name: Perfusor Space
Product Name: Perfusor Space Infusion Pump System
Model/Catalog Number: 8713030U
Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each
Component: Open, Classified |
FRN | None listed |
| Jul 25, 2024 | B Braun Medical Inc Brand Name: Perfusor Space
Product Name: Perfusor Space Syringe Pump, Wireless
Model/Catalog Number: 8713031U
Software Version: 8713031U
Product Description: Perfusor Space Syringe Pump, Infusion Pump Open, Classified |
FRN | None listed |
| Jul 25, 2024 | B Braun Medical Inc Brand Name: Perfusor Space
Product Name: Perfusor Space Syringe Pump, Non-Wireless
Model/Catalog Number: 8713032U
Product Description: Perfusor Space Syringe Pump, Non-Wireless, Infusion Pump, 1 each
Open, Classified |
FRN | None listed |
| Feb 7, 2022 | B Braun Medical Inc PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions
Catalog Number: 8713030U Terminated |
MEA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.