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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 the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-07-16 under 510(k) 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. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K211525.

When did SwiftNINJA Steerable Microcatheter receive FDA 510(k) clearance?

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

Who is the listed applicant for SwiftNINJA Steerable Microcatheter?

The FDA 510(k) record lists Merit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SwiftNINJA Steerable Microcatheter?

The FDA product code for SwiftNINJA Steerable Microcatheter is KRA.

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Related Devices (Code: KRA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech LimitedK231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)Transit Scientific, LLCK231279Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmAblative Solutions, 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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