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FDA 510(k)

SwiftNINJA Steerable Microcatheter

K-Number: K211525 · 2021-07-16

ApplicantMerit Medical Systems, Inc.
Decision Date2021-07-16
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SwiftNINJA Steerable Microcatheter is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-07-16 under approval number K211525. 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 Steerable Microcatheter?

SwiftNINJA Steerable Microcatheter is a medical device that received FDA 510(k) clearance on 2021-07-16. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K211525.

When was SwiftNINJA Steerable Microcatheter approved by the FDA?

SwiftNINJA Steerable Microcatheter received FDA 510(k) clearance on 2021-07-16, under approval number K211525.

What company makes SwiftNINJA Steerable Microcatheter?

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

What is the FDA product code for SwiftNINJA Steerable Microcatheter?

The FDA product code for SwiftNINJA Steerable Microcatheter is KRA.

Other Devices by Merit Medical Systems, Inc.

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Related Devices (Code: KRA)

K161962VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC K160884CXI Support CatheterCook Incorporated K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc. K161402Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. K161801CrossCath Support CatheterCook Incorporated K153501Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc.

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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