Clearance Summary
SAFE-1 VENOUS RESERVOIR received FDA 510(k) clearance under submission number K893705, sponsored by Polystan C/O Vitalcor, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1989-12-22.
- Submission: K893705
- Applicant / Sponsor: Polystan C/O Vitalcor, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4400
- Decision date: 1989-12-22
Classification & Regulation
This clearance is catalogued under FDA product code DTN and 21 CFR 870.4400, within the Cardiovascular review panel as a Class II device.