Clearance Summary
TORQUE HEX WRENCH received FDA 510(k) clearance under submission number K875147, 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 1988-01-27.
- Submission: K875147
- Applicant / Sponsor: Cardiac Pacemakers, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.3730
- Decision date: 1988-01-27
Classification & Regulation
This clearance is catalogued under FDA product code DTF and 21 CFR 870.3730, within the Cardiovascular review panel as a Class I device.