TruDi NAV Wire
K-Number: K190532 · 2019-05-03
ApplicantAcclarent, Inc.
Decision Date2019-05-03
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
TruDi NAV Wire is a medical device manufactured by Acclarent, Inc.. It received FDA 510(k) clearance on 2019-05-03 under approval number K190532. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TruDi NAV Wire?
TruDi NAV Wire is a medical device that received FDA 510(k) clearance on 2019-05-03. It is manufactured by Acclarent, Inc.. The 510(k) number is K190532.
When was TruDi NAV Wire approved by the FDA?
TruDi NAV Wire received FDA 510(k) clearance on 2019-05-03, under approval number K190532.
What company makes TruDi NAV Wire?
TruDi NAV Wire is manufactured by Acclarent, Inc..
What is the FDA product code for TruDi NAV Wire?
The FDA product code for TruDi NAV Wire is PGW.
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K171687Relieva SpinPlus Nav Balloon Sinuplasty System
K180948TruDi NAV Suction Instruments
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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.