Clearance Summary
ORIGEN REINFORCED DUAL LUMEN CATHETER received FDA 510(k) clearance under submission number K113869, sponsored by Origen Biomedical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-07-26.
- Submission: K113869
- Applicant / Sponsor: Origen Biomedical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4210
- Decision date: 2012-07-26
Classification & Regulation
This clearance is catalogued under FDA product code DWF and 21 CFR 870.4210, within the Cardiovascular review panel as a Class II device.