FDA 510(k)

AcQGuide MAX Steerable Sheath

K-Number: K211100 · 2021-05-14

Decision Date2021-05-14

Product CodeDRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AcQGuide MAX Steerable Sheath is a medical device manufactured by Acutus Medical, Inc.. It received FDA 510(k) clearance on 2021-05-14 under approval number K211100. 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 MAX Steerable Sheath?

AcQGuide MAX Steerable Sheath is a medical device that received FDA 510(k) clearance on 2021-05-14. It is manufactured by Acutus Medical, Inc.. The 510(k) number is K211100.

When was AcQGuide MAX Steerable Sheath approved by the FDA?

AcQGuide MAX Steerable Sheath received FDA 510(k) clearance on 2021-05-14, under approval number K211100.

What company makes AcQGuide MAX Steerable Sheath?

AcQGuide MAX Steerable Sheath is manufactured by Acutus Medical, Inc..

What is the FDA product code for AcQGuide MAX Steerable Sheath?

The FDA product code for AcQGuide MAX 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.