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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 the device name listed in this FDA 510(k) record. The listed applicant is Acutus Medical, Inc.. It received FDA 510(k) clearance on 2022-05-05 under 510(k) 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. The listed applicant is Acutus Medical, Inc.. The 510(k) number is K221044.

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

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

Who is the listed applicant for AcQGuide® VUE 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® VUE Steerable Sheath?

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

Other records listing Acutus Medical, Inc. as applicant

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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.

K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific CorporationK250529Globe Introducer (601-01001)Kardium, Inc.K233248FARADRIVE™ Steerable SheathBoston Scientific CorporationK232321FlexCath Contour™ Steerable SheathMedtronic, Inc.K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure SensorBoston Scientific CorporationK221397MitraClip G4 Steerable Guide CatheterABBOTT MEDICAL

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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