Bendit2.7 Steerable Microcatheter

FDA 510(k) K190126 · Bend IT Technologies, Ltd.

Substantially Equivalent

510(k) numberK190126

Submission

Device name
Bendit2.7 Steerable Microcatheter
Applicant
Bend IT Technologies, Ltd.
Petach Tikva, IL
Received
January 28, 2019
Decision date
August 22, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQO – Catheter, Intravascular, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1200
Specialty
Cardiovascular

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K250751DualView CatheterDQO · Traditional Terumo Corporation07/17/2025SE
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K242420pNOVUS 21 MicrocatheterDQO · Traditional Phenox, Ltd.11/12/2024SE
K233268Impress Angiographic CatheterDQO · Special Merit Medical Systems, Inc.05/22/2024SE
K233975Zoom 6F Insert CathetersDQO · Traditional Imperative Care, Inc.04/02/2024SE
K232536Soldier MicrocatheterDQO · Traditional Embolx, Inc.02/23/2024SE
K232573INFINITI™ Ambi Angiographic CatheterDQO · Traditional Cordis US Corp11/21/2023SE

More from Cordis US Corp

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K200582Bendit2.7 Steerable MicrocatheterKRA · Traditional 06/25/2020SE

Questions and answers

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

Bendit2.7 Steerable Microcatheter (K190126) received a 510(k) decision of Substantially Equivalent on August 22, 2019, 206 days after the submission was received.

What is the product code of K190126?

The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.