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FDA 510(k)

NAVIS TORQUER

K-Number: K112674 · 2012-07-06

ApplicantNavis Medical,Inc
Decision Date2012-07-06
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NAVIS TORQUER is the device name listed in this FDA 510(k) record. The listed applicant is Navis Medical,Inc. It received FDA 510(k) clearance on 2012-07-06 under 510(k) number K112674. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIS TORQUER?

NAVIS TORQUER is a medical device that received FDA 510(k) clearance on 2012-07-06. The listed applicant is Navis Medical,Inc. The 510(k) number is K112674.

When did NAVIS TORQUER receive FDA 510(k) clearance?

NAVIS TORQUER received FDA 510(k) clearance on 2012-07-06, under 510(k) number K112674.

Who is the listed applicant for NAVIS TORQUER?

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

What is the FDA product code for NAVIS TORQUER?

The FDA product code for NAVIS TORQUER is DQX.

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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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