Acutus Medical, Inc.
Acutus Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 2017, most recent 2023, with 4 FDA device recalls on record.
Top product codes for Acutus Medical, Inc.
FDA recalls by Acutus Medical, Inc.
- Z-1769-2020 — Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
- Z-1768-2020 — Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
- Z-1771-2020 — Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
- Z-1770-2020 — Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Acutus Medical, Inc.
- K233691 — FlexCath Cross Transseptal Solution
- K231091 — AcQMap High Resolution Imaging and Mapping System
- K230606 — AcQMap® High Resolution Imaging and Mapping System
- K222209 — AcQMap High Resolution Imaging and Mapping System
- K220784 — AcQMap High Resolution Imaging and Mapping System
- K210766 — AcQMap 3D Imaging and Mapping Catheter, Model 900009
- K221044 — AcQGuide® VUE Steerable Sheath
- K220047 — AcQCross Qx Integrated Transseptal Dilator/Needle
- K212345 — AcQMap High Resolution Imaging and Mapping System
- K210680 — AcQMap High Resolution Imaging and Mapping System
- K211100 — AcQGuide MAX Steerable Sheath
- K210685 — AcQCross Qx Integrated Transseptal Dilator/Needle
- K201015 — AcQMap High Resolution Imaging and Mapping System
- K201341 — AcQMap 3D Imaging and Mapping Catheter
- K193013 — AcQMap High Resolution Imaging and Mapping System
- K193509 — AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX
- K191392 — AcQMap High Resolution Imaging and Mapping System
- K192106 — AcQRef Introducer Sheath
- K190131 — AcQMap High Resolution Imaging and Mapping System
- K181577 — AcQMap High Resolution Imaging and Mapping System
- K171557 — AcQRef Introducer Sheath
- K170819 — AcQMap 3D Imaging and Mapping Catheter
- K170948 — AcQMap High Resolution Imaging and Mapping System
- K162925 — AcQGuide Steerable Sheath
Data sourced from openFDA. This site is unofficial and independent of the FDA.