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FDA 510(k)

AcQGuide® VUE Steerable Sheath

K-Number: K221044 · 2022-05-05

ApplicantAcutus Medical, Inc.
Decision Date2022-05-05
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AcQGuide® VUE Steerable Sheath is a medical device manufactured by Acutus Medical, Inc.. It received FDA 510(k) clearance on 2022-05-05 under approval number K221044. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AcQGuide® VUE Steerable Sheath?

AcQGuide® VUE Steerable Sheath is a medical device that received FDA 510(k) clearance on 2022-05-05. It is manufactured by Acutus Medical, Inc.. The 510(k) number is K221044.

When was AcQGuide® VUE Steerable Sheath approved by the FDA?

AcQGuide® VUE Steerable Sheath received FDA 510(k) clearance on 2022-05-05, under approval number K221044.

What company makes AcQGuide® VUE Steerable Sheath?

AcQGuide® VUE Steerable Sheath is manufactured by Acutus Medical, Inc..

What is the FDA product code for AcQGuide® VUE Steerable Sheath?

The FDA product code for AcQGuide® VUE Steerable Sheath is DRA.

Other Devices by Acutus Medical, Inc.

K170948AcQMap High Resolution Imaging and Mapping System K170819AcQMap 3D Imaging and Mapping Catheter K162925AcQGuide Steerable Sheath K171557AcQRef Introducer Sheath K191392AcQMap High Resolution Imaging and Mapping System K192106AcQRef Introducer Sheath

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Related Devices (Code: DRA)

K160919Hansen Medical Magellan Robotic Catheter 9FrHansen Medical, Inc. K161985Steerable Guide CatheterAbbott Vascular K152310HeartLight Deflectable SheathCardiofocus, Inc. K153304Hansen Medical Magellan Robotic Catheter eKitHansen Medical, Inc. K172394Steerable Guide CatheterAbbott Vascular K162925AcQGuide Steerable SheathAcutus Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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