Clearance Summary
APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH received FDA 510(k) clearance under submission number K140036, sponsored by Aptus Endosystems, 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 2014-02-06.
- Submission: K140036
- Applicant / Sponsor: Aptus Endosystems, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3460
- Decision date: 2014-02-06
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.