Clearance Summary
AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) received FDA 510(k) clearance under submission number K971984, sponsored by Microvena Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1997-09-19.
- Submission: K971984
- Applicant / Sponsor: Microvena Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4875
- Decision date: 1997-09-19
Classification & Regulation
This clearance is catalogued under FDA product code MCW and 21 CFR 870.4875, within the Cardiovascular review panel as a Class II device.