510(k) K150267
K150267 is an FDA 510(k) premarket notification submitted by Maquet Cardiopulmonary, AG for the device "QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators". The FDA issued a decision of Substantially Equivalent on May 7, 2015. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Maquet Cardiopulmonary, AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 2015
- Date Received
- February 4, 2015
- 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