Clearance Summary
CARDIO-PAK BASIC PUMP PACK received FDA 510(k) clearance under submission number K923231, sponsored by Cardio-Med-Associates, 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 1993-07-09.
- Submission: K923231
- Applicant / Sponsor: Cardio-Med-Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4390
- Decision date: 1993-07-09
Classification & Regulation
This clearance is catalogued under FDA product code DWE and 21 CFR 870.4390, within the Cardiovascular review panel as a Class II device.