Clearance Summary
PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP received FDA 510(k) clearance under submission number K910609, sponsored by Biotronik, GmbH & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1991-08-28.
- Submission: K910609
- Applicant / Sponsor: Biotronik, GmbH & Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3680
- Decision date: 1991-08-28
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.