510(k) K790756
K790756 is an FDA 510(k) premarket notification submitted by Delta Medical Industries for the device "HEAT EXCHANGER COIL". The FDA issued a decision of Substantially Equivalent on June 11, 1979. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. Delta Medical Industries has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 1979
- Date Received
- April 17, 1979
- 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