Clearance Summary
Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set received FDA 510(k) clearance under submission number K162181, sponsored by Cardiacassist, 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 2017-01-06.
- Submission: K162181
- Applicant / Sponsor: Cardiacassist, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1310
- Decision date: 2017-01-06
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.