Medtronic Confida Brecker Guidewire
K-Number: K181001 · 2018-05-03
ApplicantMedtronic Core Valve, LLC
Decision Date2018-05-03
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Medtronic Confida Brecker Guidewire is a medical device manufactured by Medtronic Core Valve, LLC. It received FDA 510(k) clearance on 2018-05-03 under approval number K181001. 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 Medtronic Confida Brecker Guidewire?
Medtronic Confida Brecker Guidewire is a medical device that received FDA 510(k) clearance on 2018-05-03. It is manufactured by Medtronic Core Valve, LLC. The 510(k) number is K181001.
When was Medtronic Confida Brecker Guidewire approved by the FDA?
Medtronic Confida Brecker Guidewire received FDA 510(k) clearance on 2018-05-03, under approval number K181001.
What company makes Medtronic Confida Brecker Guidewire?
Medtronic Confida Brecker Guidewire is manufactured by Medtronic Core Valve, LLC.
What is the FDA product code for Medtronic Confida Brecker Guidewire?
The FDA product code for Medtronic Confida Brecker Guidewire 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.