510(k) K910107
K910107 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD". The FDA issued a decision of Substantially Equivalent on Apr 10, 1991. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 10, 1991
- Date Received
- Jan 10, 1991
- 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)