Clearance Summary
CAPIOX RX HARDSHELL RESERVOIR received FDA 510(k) clearance under submission number K013526, sponsored by Terumo Cardiovascular Systems Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-11-15.
- Submission: K013526
- Applicant / Sponsor: Terumo Cardiovascular Systems Corp.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4400
- Decision date: 2001-11-15
Classification & Regulation
This clearance is catalogued under FDA product code DTN and 21 CFR 870.4400, within the Cardiovascular review panel as a Class II device.