FDA 510(k)

Twin-Pass Torque

K-Number: K162467 · 2017-02-01

Decision Date2017-02-01

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Twin-Pass Torque is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2017-02-01 under 510(k) number K162467. 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 Twin-Pass Torque?

Twin-Pass Torque is a medical device that received FDA 510(k) clearance on 2017-02-01. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K162467.

When did Twin-Pass Torque receive FDA 510(k) clearance?

Twin-Pass Torque received FDA 510(k) clearance on 2017-02-01, under 510(k) number K162467.

Who is the listed applicant for Twin-Pass Torque?

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

What is the FDA product code for Twin-Pass Torque?

The FDA product code for Twin-Pass Torque is DQY.

Other records listing Vascular Solutions, Inc. as applicant

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.