Clearance Summary
APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH received FDA 510(k) clearance under submission number K121168, sponsored by Aptus Endosystems, 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 2012-08-08.
- Submission: K121168
- Applicant / Sponsor: Aptus Endosystems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3460
- Decision date: 2012-08-08
Classification & Regulation
This clearance is catalogued under FDA product code OTD and 21 CFR 870.3460, within the Cardiovascular review panel as a Class II device.