Clearance Summary
SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER received FDA 510(k) clearance under submission number K881197, sponsored by Schneider-Shilley (Usa). The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1988-05-16.
- Submission: K881197
- Applicant / Sponsor: Schneider-Shilley (Usa)
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 1988-05-16
Classification & Regulation
This clearance is catalogued under FDA product code LIT and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.