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FDA 510(k)

SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter

K-Number: K210647 · 2021-04-30

ApplicantVascular Solutions, LLC
Decision Date2021-04-30
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, LLC. It received FDA 510(k) clearance on 2021-04-30 under 510(k) number K210647. 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 SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter?

SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter is a medical device that received FDA 510(k) clearance on 2021-04-30. The listed applicant is Vascular Solutions, LLC. The 510(k) number is K210647.

When did SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter receive FDA 510(k) clearance?

SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter received FDA 510(k) clearance on 2021-04-30, under 510(k) number K210647.

Who is the listed applicant for SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter?

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

What is the FDA product code for SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter?

The FDA product code for SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter is DQY.

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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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