Instylla Microcatheter
K-Number: K191731 · 2019-08-13
ApplicantInstylla, Inc.
Decision Date2019-08-13
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Instylla Microcatheter is a medical device manufactured by Instylla, Inc.. It received FDA 510(k) clearance on 2019-08-13 under approval number K191731. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Instylla Microcatheter?
Instylla Microcatheter is a medical device that received FDA 510(k) clearance on 2019-08-13. It is manufactured by Instylla, Inc.. The 510(k) number is K191731.
When was Instylla Microcatheter approved by the FDA?
Instylla Microcatheter received FDA 510(k) clearance on 2019-08-13, under approval number K191731.
What company makes Instylla Microcatheter?
Instylla Microcatheter is manufactured by Instylla, Inc..
What is the FDA product code for Instylla Microcatheter?
The FDA product code for Instylla Microcatheter is KRA.
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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.