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FDA 510(k)

DISPOSABLE TORQUE DEVICE

K-Number: K113498 · 2012-07-20

ApplicantCoeur, Inc.
Decision Date2012-07-20
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE TORQUE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Coeur, Inc.. It received FDA 510(k) clearance on 2012-07-20 under 510(k) number K113498. 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 DISPOSABLE TORQUE DEVICE?

DISPOSABLE TORQUE DEVICE is a medical device that received FDA 510(k) clearance on 2012-07-20. The listed applicant is Coeur, Inc.. The 510(k) number is K113498.

When did DISPOSABLE TORQUE DEVICE receive FDA 510(k) clearance?

DISPOSABLE TORQUE DEVICE received FDA 510(k) clearance on 2012-07-20, under 510(k) number K113498.

Who is the listed applicant for DISPOSABLE TORQUE DEVICE?

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

What is the FDA product code for DISPOSABLE TORQUE DEVICE?

The FDA product code for DISPOSABLE TORQUE DEVICE is DQX.

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Related Devices (Code: DQX)

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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