Clearance Summary
VIEWFLEX XTRA ICE CATHETER received FDA 510(k) clearance under submission number K133853, sponsored by Irvine Biomedical, Inc., A St. Jude Medical Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-05-19.
- Submission: K133853
- Applicant / Sponsor: Irvine Biomedical, Inc., A St. Jude Medical Company
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2014-05-19
Classification & Regulation
This clearance is catalogued under FDA product code OBJ and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.