Clearance Summary
3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON received FDA 510(k) clearance under submission number K093515, sponsored by Brivant, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-02-16.
- Submission: K093515
- Applicant / Sponsor: Brivant, Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2010-02-16
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.