Clearance Summary
JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 received FDA 510(k) clearance under submission number K982136, sponsored by Schiff & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-03-24.
- Submission: K982136
- Applicant / Sponsor: Schiff & Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4400
- Decision date: 1999-03-24
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.