Clearance Summary
A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE. received FDA 510(k) clearance under submission number K902889, 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 1990-08-23.
- Submission: K902889
- Applicant / Sponsor: Biotronik, GmbH & Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3620
- Decision date: 1990-08-23
Classification & Regulation
This clearance is catalogued under FDA product code DTD and 21 CFR 870.3620, within the Cardiovascular review panel as a Class II device.