True Form Reshapable Guide Wire
K-Number: K170532 · 2017-07-21
ApplicantMerit Medical Systems, Inc.
Decision Date2017-07-21
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
True Form Reshapable Guide Wire is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-07-21 under approval number K170532. 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 True Form Reshapable Guide Wire?
True Form Reshapable Guide Wire is a medical device that received FDA 510(k) clearance on 2017-07-21. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K170532.
When was True Form Reshapable Guide Wire approved by the FDA?
True Form Reshapable Guide Wire received FDA 510(k) clearance on 2017-07-21, under approval number K170532.
What company makes True Form Reshapable Guide Wire?
True Form Reshapable Guide Wire is manufactured by Merit Medical Systems, Inc..
What is the FDA product code for True Form Reshapable Guide Wire?
The FDA product code for True Form Reshapable Guide Wire 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.