Clearance Summary
BLOOD PUMP-MODE S10K received FDA 510(k) clearance under submission number K780410, sponsored by 3M Health Care, Sarns. 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 1978-05-03.
- Submission: K780410
- Applicant / Sponsor: 3M Health Care, Sarns
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1978-05-03
Classification & Regulation
This clearance is catalogued under FDA product code FIR and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.