Roadrunner PC Wire Guide, Olcott Torque Device
K-Number: K182985 · 2019-07-22
ApplicantCook Incorporated
Decision Date2019-07-22
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Roadrunner PC Wire Guide, Olcott Torque Device is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2019-07-22 under approval number K182985. 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 Roadrunner PC Wire Guide, Olcott Torque Device?
Roadrunner PC Wire Guide, Olcott Torque Device is a medical device that received FDA 510(k) clearance on 2019-07-22. It is manufactured by Cook Incorporated. The 510(k) number is K182985.
When was Roadrunner PC Wire Guide, Olcott Torque Device approved by the FDA?
Roadrunner PC Wire Guide, Olcott Torque Device received FDA 510(k) clearance on 2019-07-22, under approval number K182985.
What company makes Roadrunner PC Wire Guide, Olcott Torque Device?
Roadrunner PC Wire Guide, Olcott Torque Device is manufactured by Cook Incorporated.
What is the FDA product code for Roadrunner PC Wire Guide, Olcott Torque Device?
The FDA product code for Roadrunner PC Wire Guide, Olcott Torque Device 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.