AcQGuide Steerable Sheath
K-Number: K162925 · 2017-04-06
ApplicantAcutus Medical, Inc.
Decision Date2017-04-06
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
AcQGuide Steerable Sheath is a medical device manufactured by Acutus Medical, Inc.. It received FDA 510(k) clearance on 2017-04-06 under approval 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. It is manufactured by Acutus Medical, Inc.. The 510(k) number is K162925.
When was AcQGuide Steerable Sheath approved by the FDA?
AcQGuide Steerable Sheath received FDA 510(k) clearance on 2017-04-06, under approval number K162925.
What company makes AcQGuide Steerable Sheath?
AcQGuide Steerable Sheath is manufactured by Acutus Medical, Inc..
What is the FDA product code for AcQGuide Steerable Sheath?
The FDA product code for AcQGuide Steerable Sheath is DRA.
Other Devices by Acutus Medical, Inc.
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K183174FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP
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.