FDA 510(k)

Bendit2.7 Steerable Microcatheter

K-Number: K200582 · 2020-06-25

Decision Date2020-06-25

Product CodeKRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Bendit2.7 Steerable Microcatheter is a medical device manufactured by Bend IT Technologies, Ltd.. It received FDA 510(k) clearance on 2020-06-25 under approval number K200582. 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 Bendit2.7 Steerable Microcatheter?

Bendit2.7 Steerable Microcatheter is a medical device that received FDA 510(k) clearance on 2020-06-25. It is manufactured by Bend IT Technologies, Ltd.. The 510(k) number is K200582.

When was Bendit2.7 Steerable Microcatheter approved by the FDA?

Bendit2.7 Steerable Microcatheter received FDA 510(k) clearance on 2020-06-25, under approval number K200582.

What company makes Bendit2.7 Steerable Microcatheter?

Bendit2.7 Steerable Microcatheter is manufactured by Bend IT Technologies, Ltd..

What is the FDA product code for Bendit2.7 Steerable Microcatheter?

The FDA product code for Bendit2.7 Steerable Microcatheter is KRA.

Other Devices by Bend IT Technologies, Ltd.

K190126Bendit2.7 Steerable Microcatheter K203842Bendit21 Microcatheter K252213Bendit17 Microcatheter

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.