Merit Hydrophilic Guide Wire
K-Number: K201595 · 2020-10-14
ApplicantMerit Medical Systems, Inc.
Decision Date2020-10-14
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Merit Hydrophilic Guide Wire is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2020-10-14 under approval number K201595. 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 Merit Hydrophilic Guide Wire?
Merit Hydrophilic Guide Wire is a medical device that received FDA 510(k) clearance on 2020-10-14. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K201595.
When was Merit Hydrophilic Guide Wire approved by the FDA?
Merit Hydrophilic Guide Wire received FDA 510(k) clearance on 2020-10-14, under approval number K201595.
What company makes Merit Hydrophilic Guide Wire?
Merit Hydrophilic Guide Wire is manufactured by Merit Medical Systems, Inc..
What is the FDA product code for Merit Hydrophilic Guide Wire?
The FDA product code for Merit Hydrophilic 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.