NovaCross CTO Microcatheter
K-Number: K193322 · 2020-04-02
ApplicantNitiloop , Ltd.
Decision Date2020-04-02
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
NovaCross CTO Microcatheter is a medical device manufactured by Nitiloop , Ltd.. It received FDA 510(k) clearance on 2020-04-02 under approval number K193322. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NovaCross CTO Microcatheter?
NovaCross CTO Microcatheter is a medical device that received FDA 510(k) clearance on 2020-04-02. It is manufactured by Nitiloop , Ltd.. The 510(k) number is K193322.
When was NovaCross CTO Microcatheter approved by the FDA?
NovaCross CTO Microcatheter received FDA 510(k) clearance on 2020-04-02, under approval number K193322.
What company makes NovaCross CTO Microcatheter?
NovaCross CTO Microcatheter is manufactured by Nitiloop , Ltd..
What is the FDA product code for NovaCross CTO Microcatheter?
The FDA product code for NovaCross CTO Microcatheter is DQY.
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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.