510(k) K183511 · DTZ Oxygenator, Cardiopulmonary Bypass
Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoi
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Mar 18, 2019 |
| Received | Dec 18, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183511
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2021 | Medtronic Perfusion Systems Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CV Terminated |
DTN | None listed |
| Mar 17, 2021 | Medtronic Perfusion Systems Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie Cardiotomy/Venous Reservoir Terminated |
DTN | None listed |
| Mar 17, 2021 | Medtronic Perfusion Systems Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is
a single-use device designed to collect and store blood Terminated |
DTN | None listed |
| Mar 17, 2021 | Medtronic Perfusion Systems Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is
a single-use device design Terminated |
DTN | None listed |
| Mar 17, 2021 | Medtronic Perfusion Systems Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is
a single-use device designed to collect and Terminated |
DTN | None listed |
| Mar 17, 2021 | Medtronic Perfusion Systems Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is
a single-use device designed to collect and store Terminated |
DTN | None listed |
| Mar 17, 2021 | Medtronic Perfusion Systems Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is
a single-use device designed to collect and store blood during ext Terminated |
DTN | None listed |
| Mar 17, 2021 | Medtronic Perfusion Systems Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is
a single-use device designed to colle Terminated |
DTN | None listed |
| Mar 17, 2021 | Medtronic Perfusion Systems Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is
a single-use device designed to collect and Terminated |
DTN | None listed |
| Mar 17, 2021 | Medtronic Perfusion Systems Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is
a single-use device designed to collect and store blood during Terminated |
DTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.