Clearance Summary
HYDROFIX VASO SHIELD received FDA 510(k) clearance under submission number K111137, sponsored by Mimedx Group, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-05-20.
- Submission: K111137
- Applicant / Sponsor: Mimedx Group, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3470
- Decision date: 2011-05-20
Classification & Regulation
This clearance is catalogued under FDA product code OMR and 21 CFR 870.3470, within the Cardiovascular review panel as a Class II device.