510(k) K770681
K770681 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR". The FDA issued a decision of Substantially Equivalent on Apr 26, 1977. The device falls under product code KRI (Accessory Equipment, Cardiopulmonary Bypass), a Class I device regulated under 21 CFR 870.4200. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 26, 1977
- Date Received
- Apr 11, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Accessory Equipment, Cardiopulmonary Bypass
- Device Class
- Class I
- Regulation Number
- 870.4200
- Review Panel
- CV
- Submission Type
- 510(k) Exempt