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510(k) K211100

AcQGuide MAX Steerable Sheath by Acutus Medical, Inc. — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2021
Date Received
April 13, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Catheter, Steerable
Device Class
Class II
Regulation Number
870.1280
Review Panel
CV
Submission Type

Other clearances by Acutus Medical, Inc.

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  • K222209 — AcQMap High Resolution Imaging and Mapping System (October 17, 2022)
  • K220784 — AcQMap High Resolution Imaging and Mapping System (July 1, 2022)
  • K210766 — AcQMap 3D Imaging and Mapping Catheter, Model 900009 (June 21, 2022)
  • K221044 — AcQGuide® VUE Steerable Sheath (May 5, 2022)
  • K220047 — AcQCross Qx Integrated Transseptal Dilator/Needle (February 8, 2022)
  • K212345 — AcQMap High Resolution Imaging and Mapping System (August 27, 2021)
  • K210680 — AcQMap High Resolution Imaging and Mapping System (August 5, 2021)

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  • K223824 — POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping (March 22, 2023)
  • K221397 — MitraClip G4 Steerable Guide Catheter (September 28, 2022)
  • K221044 — AcQGuide® VUE Steerable Sheath (May 5, 2022)
  • K202620 — FlexCath Advance Steerable Sheath and Dilator (November 13, 2020)
  • K192422 — Steerable Introducer 12F (October 4, 2019)
  • K190167 — MitraClip G4 Steerable Guide Catheter (May 29, 2019)
  • K183174 — FlexCath Advance Steerable Sheath and Dilator (November 26, 2018)