Clearance Summary
SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT received FDA 510(k) clearance under submission number K915547, sponsored by 3M Health Care, Sarns. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1993-09-09.
- Submission: K915547
- Applicant / Sponsor: 3M Health Care, Sarns
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4360
- Decision date: 1993-09-09
Classification & Regulation
This clearance is catalogued under FDA product code KFM and 21 CFR 870.4360, within the Cardiovascular review panel as a Class II device.