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510(k) K140036

APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH by Aptus Endosystems, Inc. — Product Code OTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2014
Date Received
January 7, 2014
Clearance Type
Special
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)
  • K130677 — APTUS HELI-FX AORTIC SECUREMENT SYSTEM (April 12, 2013)
  • K121168 — APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH (August 8, 2012)
  • DEN100026 — APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAP (November 21, 2011)

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)
  • K130677 — APTUS HELI-FX AORTIC SECUREMENT SYSTEM (April 12, 2013)
  • K121168 — APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH (August 8, 2012)
  • DEN100026 — APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAP (November 21, 2011)