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FDA 510(k)

Wedge Microcatheter

K-Number: K172014 · 2018-04-05

ApplicantMicroVention, Inc.
Decision Date2018-04-05
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wedge Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2018-04-05 under 510(k) number K172014. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wedge Microcatheter?

Wedge Microcatheter is a medical device that received FDA 510(k) clearance on 2018-04-05. The listed applicant is MicroVention, Inc.. The 510(k) number is K172014.

When did Wedge Microcatheter receive FDA 510(k) clearance?

Wedge Microcatheter received FDA 510(k) clearance on 2018-04-05, under 510(k) number K172014.

Who is the listed applicant for Wedge Microcatheter?

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

What is the FDA product code for Wedge Microcatheter?

The FDA product code for Wedge Microcatheter is DQY.

Other records listing MicroVention, Inc. as applicant

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Related Devices (Code: DQY)

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.

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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.

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