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FDA 510(k)

SwiftNINJA Microcatheter

K-Number: K161921 · 2016-11-04

ApplicantMerit Medical Systems, Inc.
Decision Date2016-11-04
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SwiftNINJA Microcatheter is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-11-04 under approval number K161921. 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 SwiftNINJA Microcatheter?

SwiftNINJA Microcatheter is a medical device that received FDA 510(k) clearance on 2016-11-04. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K161921.

When was SwiftNINJA Microcatheter approved by the FDA?

SwiftNINJA Microcatheter received FDA 510(k) clearance on 2016-11-04, under approval number K161921.

What company makes SwiftNINJA Microcatheter?

SwiftNINJA Microcatheter is manufactured by Merit Medical Systems, Inc..

What is the FDA product code for SwiftNINJA Microcatheter?

The FDA product code for SwiftNINJA 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.

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