510(k) K050805 ยท BRZ Set, Blood Transfusion
30 ML OR 60 ML PEDI-SYRINGE FILTER
| Applicant | Blood Products Specialties, LLC, Oceanside NY, US |
| Decision | Substantially Equivalent, Jun 20, 2005 |
| Received | Mar 30, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050805
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2014 | Genesis BPS, LLC. Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe
Rx Only Genesis BPS, LLC
The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plas Terminated |
BRZ | None listed |
| Sep 18, 2014 | Genesis BPS, LLC. Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe
Rx Only Genesis BPS, LLC
The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platel Terminated |
BRZ | None listed |
| Sep 18, 2014 | Genesis BPS, LLC. Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe
Rx Only Genesis BPS, LLC
The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and Terminated |
BRZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.