Clearance Summary
PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 received FDA 510(k) clearance under submission number K000763, sponsored by Biotronik, GmbH & Co.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-04-06.
- Submission: K000763
- Applicant / Sponsor: Biotronik, GmbH & Co.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3680
- Decision date: 2000-04-06
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.