Inno-Pathwire
K-Number: K182553 · 2019-03-11
Decision Date2019-03-11
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Inno-Pathwire is a medical device manufactured by Suzhou Innomed Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2019-03-11 under approval number K182553. 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 Inno-Pathwire?
Inno-Pathwire is a medical device that received FDA 510(k) clearance on 2019-03-11. It is manufactured by Suzhou Innomed Medical Device Co., Ltd.. The 510(k) number is K182553.
When was Inno-Pathwire approved by the FDA?
Inno-Pathwire received FDA 510(k) clearance on 2019-03-11, under approval number K182553.
What company makes Inno-Pathwire?
Inno-Pathwire is manufactured by Suzhou Innomed Medical Device Co., Ltd..
What is the FDA product code for Inno-Pathwire?
The FDA product code for Inno-Pathwire 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.