510(k) K183511
K183511 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "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 Reservoir with Cortiva BioActive Surface (Model CBP241)". The FDA issued a decision of Substantially Equivalent on Mar 18, 2019. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Medtronic, Inc. has 247 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 18, 2019
- Date Received
- Dec 18, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oxygenator, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4350
- Review Panel
- CV
- Submission Type
- 510(k)