FDA 510(k)

Maestro Microcatheter

K-Number: K230636 · 2023-03-30

Decision Date2023-03-30

Product CodeKRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Maestro Microcatheter is a medical device manufactured by Merit Medical System, Inc.. It received FDA 510(k) clearance on 2023-03-30 under approval number K230636. 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 Maestro Microcatheter?

Maestro Microcatheter is a medical device that received FDA 510(k) clearance on 2023-03-30. It is manufactured by Merit Medical System, Inc.. The 510(k) number is K230636.

When was Maestro Microcatheter approved by the FDA?

Maestro Microcatheter received FDA 510(k) clearance on 2023-03-30, under approval number K230636.

What company makes Maestro Microcatheter?

Maestro Microcatheter is manufactured by Merit Medical System, Inc..

What is the FDA product code for Maestro Microcatheter?

The FDA product code for Maestro Microcatheter is KRA.

Other Devices by Merit Medical System, Inc.

K193571Go2Wire Guide Wire K212817Merit Siege Vascular Plug K231468SCOUT MD Surgical Guidance System K252527Surfacer Inside-Out Access Catheter System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.