Clearance Summary
CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS received FDA 510(k) clearance under submission number K991594, sponsored by Sangstat Medical Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1999-08-05.
- Submission: K991594
- Applicant / Sponsor: Sangstat Medical Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5880
- Decision date: 1999-08-05
Classification & Regulation
This clearance is catalogued under FDA product code MSB and 21 CFR 876.5880, within the Gastroenterology, Urology review panel as a Class II device.