Clearance Summary
OUTBACK Elite Re-Entry Catheter received FDA 510(k) clearance under submission number K150836, sponsored by Cordis Corporation, A Johnson & Johnson Co.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2015-04-29.
- Submission: K150836
- Applicant / Sponsor: Cordis Corporation, A Johnson & Johnson Co.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2015-04-29
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.