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510(k) K141041

APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE by Aptus Endosystems — Product Code OTD

K141041 is an FDA 510(k) premarket notification submitted by Aptus Endosystems for the device "APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE". The FDA issued a decision of Substantially Equivalent on May 16, 2014. The device falls under product code OTD (Endovascular Suturing System), a Class II device regulated under 21 CFR 870.3460. Aptus Endosystems has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2014
Date Received
April 23, 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

  • 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)
  • 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)
  • 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)
  • DEN100026 — APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAP (November 21, 2011)

FDA data resources