Clearance Summary
KSEA MODEL 383320 20 ANGIOMAT received FDA 510(k) clearance under submission number K960486, sponsored by Karl Storz Endoscopy. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1996-10-25.
- Submission: K960486
- Applicant / Sponsor: Karl Storz Endoscopy
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1800
- Decision date: 1996-10-25
Classification & Regulation
This clearance is catalogued under FDA product code DQI and 21 CFR 870.1800, within the Cardiovascular review panel as a Class II device.