Clearance Summary
PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE received FDA 510(k) clearance under submission number K901332, 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 1990-05-09.
- Submission: K901332
- Applicant / Sponsor: Biotronik, GmbH & Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3630
- Decision date: 1990-05-09
Classification & Regulation
This clearance is catalogued under FDA product code DTC and 21 CFR 870.3630, within the Cardiovascular review panel as a Class II device.