Clearance Summary
ROTABLATOR ROTATIONAL ANGIOPLASTY received FDA 510(k) clearance under submission number K953997, sponsored by Heart Technology Mfg., 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 1995-12-22.
- Submission: K953997
- Applicant / Sponsor: Heart Technology Mfg., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4875
- Decision date: 1995-12-22
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.