510(k) K772117
K772117 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "HEAT EXCHANGER, DISP., OMNITHERM". The FDA issued a decision of Substantially Equivalent on Mar 2, 1978. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 2, 1978
- Date Received
- Nov 8, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Heat-Exchanger, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4240
- Review Panel
- CV
- Submission Type
- 510(k)