AcQRef Introducer Sheath
K-Number: K171557 · 2018-02-06
ApplicantAcutus Medical, Inc.
Decision Date2018-02-06
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
AcQRef Introducer Sheath is a medical device manufactured by Acutus Medical, Inc.. It received FDA 510(k) clearance on 2018-02-06 under approval number K171557. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AcQRef Introducer Sheath?
AcQRef Introducer Sheath is a medical device that received FDA 510(k) clearance on 2018-02-06. It is manufactured by Acutus Medical, Inc.. The 510(k) number is K171557.
When was AcQRef Introducer Sheath approved by the FDA?
AcQRef Introducer Sheath received FDA 510(k) clearance on 2018-02-06, under approval number K171557.
What company makes AcQRef Introducer Sheath?
AcQRef Introducer Sheath is manufactured by Acutus Medical, Inc..
What is the FDA product code for AcQRef Introducer Sheath?
The FDA product code for AcQRef Introducer Sheath is DYB.
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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.