Clearance Summary
OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 received FDA 510(k) clearance under submission number K083814, sponsored by Cordis Corp., A Johnson & Johnson Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2009-01-13.
- Submission: K083814
- Applicant / Sponsor: Cordis Corp., A Johnson & Johnson Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2009-01-13
Classification & Regulation
This clearance is catalogued under FDA product code PDU and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.