Clearance Summary
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE received FDA 510(k) clearance under submission number DEN100026, sponsored by Aptus Endosystems, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-11-21.
- Submission: DEN100026
- Applicant / Sponsor: Aptus Endosystems, Inc.
- Clearance pathway: Post-NSE
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3460
- Decision date: 2011-11-21
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.