FDA 510(k)

Bendit21 Microcatheter

K-Number: K203842 · 2022-04-13

Decision Date2022-04-13

Product CodeQJP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Bendit21 Microcatheter is a medical device manufactured by Bend IT Technologies, Ltd.. It received FDA 510(k) clearance on 2022-04-13 under approval number K203842. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bendit21 Microcatheter?

Bendit21 Microcatheter is a medical device that received FDA 510(k) clearance on 2022-04-13. It is manufactured by Bend IT Technologies, Ltd.. The 510(k) number is K203842.

When was Bendit21 Microcatheter approved by the FDA?

Bendit21 Microcatheter received FDA 510(k) clearance on 2022-04-13, under approval number K203842.

What company makes Bendit21 Microcatheter?

Bendit21 Microcatheter is manufactured by Bend IT Technologies, Ltd..

What is the FDA product code for Bendit21 Microcatheter?

The FDA product code for Bendit21 Microcatheter is QJP.

Other Devices by Bend IT Technologies, Ltd.

K190126Bendit2.7 Steerable Microcatheter K200582Bendit2.7 Steerable Microcatheter K252213Bendit17 Microcatheter

Related Devices (Code: QJP)

K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. K201682RIST Radial Access CatheterRist Neurovascular, Inc. K201518Route 92 Medical 088 Access SystemRoute 92 Medical K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. K200910BOSS Balloon Guide CatheterMarblehead Medical K200417RIST Radial Access CatheterRist Neurovascular, 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.