Clearance Summary
HEMO-CATH 10F, HEMO-CATH 12.5F received FDA 510(k) clearance under submission number K113487, sponsored by Medical Components, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2012-03-09.
- Submission: K113487
- Applicant / Sponsor: Medical Components, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2012-03-09
Classification & Regulation
This clearance is catalogued under FDA product code MSD and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.