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FDA 510(k)

AcQGuide Steerable Sheath

K-Number: K162925 · 2017-04-06

Decision Date2017-04-06
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AcQGuide Steerable Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Acutus Medical, Inc.. It received FDA 510(k) clearance on 2017-04-06 under 510(k) number K162925. 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 Steerable Sheath?

AcQGuide Steerable Sheath is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Acutus Medical, Inc.. The 510(k) number is K162925.

When did AcQGuide Steerable Sheath receive FDA 510(k) clearance?

AcQGuide Steerable Sheath received FDA 510(k) clearance on 2017-04-06, under 510(k) number K162925.

Who is the listed applicant for AcQGuide Steerable Sheath?

The FDA 510(k) record lists Acutus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AcQGuide Steerable Sheath?

The FDA product code for AcQGuide Steerable Sheath is DRA.

Other records listing Acutus Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 24 devices →

Related Devices (Code: DRA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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