Clearance Summary
NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 received FDA 510(k) clearance under submission number K853791, sponsored by Norton Performance Plastics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-12-09.
- Submission: K853791
- Applicant / Sponsor: Norton Performance Plastics Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4240
- Decision date: 1985-12-09
Classification & Regulation
This clearance is catalogued under FDA product code DTR and 21 CFR 870.4240, within the Cardiovascular review panel as a Class II device.