Clearance Summary
CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER received FDA 510(k) clearance under submission number K132197, sponsored by Pendracare International, B.V.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-08-12.
- Submission: K132197
- Applicant / Sponsor: Pendracare International, B.V.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2013-08-12
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.