Clearance Summary
KATZEN THROMBOLYSIS GUIDEWIRE received FDA 510(k) clearance under submission number K883880, sponsored by Medi-Tech, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1989-04-06.
- Submission: K883880
- Applicant / Sponsor: Medi-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 1989-04-06
Classification & Regulation
This clearance is catalogued under FDA product code DQX and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.