Clearance Summary
Attain Assist CS Access Catheter received FDA 510(k) clearance under submission number K171819, sponsored by Creganna Medical Also Doing Business AS Ceganna Tactx Medica. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-01-04.
- Submission: K171819
- Applicant / Sponsor: Creganna Medical Also Doing Business AS Ceganna Tactx Medica
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2018-01-04
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.