Home / 510(k) Clearances / DEN100026

510(k) DEN100026

APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE by Aptus Endosystems, Inc. — Product Code OTD

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
November 21, 2011
Date Received
December 14, 2010
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endovascular Suturing System
Device Class
Class II
Regulation Number
870.3460
Review Panel
CV
Submission Type

Provides fixation and sealing between and endovascular graft and the native artery.

Other clearances by Aptus Endosystems, Inc.

  • K141041 — APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE (May 16, 2014)
  • K140036 — APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLEC (February 6, 2014)
  • K130677 — APTUS HELI-FX AORTIC SECUREMENT SYSTEM (April 12, 2013)
  • K121168 — APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH (August 8, 2012)

Other clearances for product code OTD

  • K182957 — Heli-FX EndoAnchor System (November 21, 2018)
  • K171427 — Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette (June 13, 2017)
  • K141041 — APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE (May 16, 2014)
  • K140036 — APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLEC (February 6, 2014)
  • K130677 — APTUS HELI-FX AORTIC SECUREMENT SYSTEM (April 12, 2013)
  • K121168 — APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH (August 8, 2012)