Clearance Summary
VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 received FDA 510(k) clearance under submission number K022823, sponsored by Geister Medizin Technik GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-07-01.
- Submission: K022823
- Applicant / Sponsor: Geister Medizin Technik GmbH
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4885
- Decision date: 2004-07-01
Classification & Regulation
This clearance is catalogued under FDA product code MGZ and 21 CFR 870.4885, within the Cardiovascular review panel as a Class II device.