510(k) K895356
K895356 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "UNIVOX-IC". The FDA issued a decision of Substantially Equivalent on Mar 6, 1990. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 6, 1990
- Date Received
- Aug 28, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Reservoir, Blood, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4400
- Review Panel
- CV
- Submission Type
- 510(k)