Clearance Summary
UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION received FDA 510(k) clearance under submission number K953044, sponsored by Biotronik, 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 1996-09-27.
- Submission: K953044
- Applicant / Sponsor: Biotronik, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3680
- Decision date: 1996-09-27
Classification & Regulation
This clearance is catalogued under FDA product code DTB and 21 CFR 870.3680, within the Cardiovascular review panel as a Class III device.