510(k) K880451
K880451 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS". The FDA issued a decision of Substantially Equivalent on Apr 28, 1988. 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
- Apr 28, 1988
- Date Received
- Feb 2, 1988
- 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)