510(k) K133157
TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 by
Medtronic, Inc.
— Product Code DRY
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 2014
- Date Received
- October 17, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4330
- Review Panel
- CV
- Submission Type