Clearance Summary
CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR received FDA 510(k) clearance under submission number K853425, sponsored by Cardio-Pace Medical, 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 1985-08-19.
- Submission: K853425
- Applicant / Sponsor: Cardio-Pace Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3610
- Decision date: 1985-08-19
Classification & Regulation
This clearance is catalogued under FDA product code DXY and 21 CFR 870.3610, within the Cardiovascular review panel as a Class III device.