Clearance Summary
OXYGENATOR GAS LINE FILTER received FDA 510(k) clearance under submission number K792151, sponsored by Cardio Systems, 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 1979-11-13.
- Submission: K792151
- Applicant / Sponsor: Cardio Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.4200
- Decision date: 1979-11-13
Classification & Regulation
This clearance is catalogued under FDA product code KRI and 21 CFR 870.4200, within the Cardiovascular review panel as a Class I device.