510(k) K992559
K992559 is an FDA 510(k) premarket notification submitted by Jostra Bentley for the device "HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010". The FDA issued a decision of Substantially Equivalent on September 20, 1999. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Jostra Bentley has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 1999
- Date Received
- July 30, 1999
- 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