Clearance Summary
FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER received FDA 510(k) clearance under submission number K120304, sponsored by Footprint Medical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2012-03-01.
- Submission: K120304
- Applicant / Sponsor: Footprint Medical, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2012-03-01
Classification & Regulation
This clearance is catalogued under FDA product code FOS and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.