Clearance Summary
ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE received FDA 510(k) clearance under submission number K890785, sponsored by Cardiac Pacemakers, 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 1989-03-10.
- Submission: K890785
- Applicant / Sponsor: Cardiac Pacemakers, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3610
- Decision date: 1989-03-10
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.