Clearance Summary
MC3 Vascular Access Kit 21030 received FDA 510(k) clearance under submission number K182914, sponsored by Mc3 Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-10-29.
- Submission: K182914
- Applicant / Sponsor: Mc3 Incorporated
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1310
- Decision date: 2018-10-29
Classification & Regulation
This clearance is catalogued under FDA product code DRE and 21 CFR 870.1310, within the Cardiovascular review panel as a Class II device.