Clearance Summary
MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB received FDA 510(k) clearance under submission number K904556, sponsored by Boston Scientific Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1991-12-18.
- Submission: K904556
- Applicant / Sponsor: Boston Scientific Corp
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5380
- Decision date: 1991-12-18
Classification & Regulation
This clearance is catalogued under FDA product code IOL and 21 CFR 890.5380, within the Physical Medicine review panel as a Class I device.