Clearance Summary
KAVS - CATHETER, MODELS 1107100 & 1107060 received FDA 510(k) clearance under submission number K052844, sponsored by Richter & Rothe AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-03-20.
- Submission: K052844
- Applicant / Sponsor: Richter & Rothe AG
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4450
- Decision date: 2006-03-20
Classification & Regulation
This clearance is catalogued under FDA product code MJN and 21 CFR 870.4450, within the Cardiovascular review panel as a Class II device.