Bendit2.7 Steerable Microcatheter

FDA 510(k) K200582 · Bend IT Technologies, Ltd.

Substantially Equivalent

510(k) numberK200582

Submission

Device name
Bendit2.7 Steerable Microcatheter
Applicant
Bend IT Technologies, Ltd.
Petach Tikva, IL
Received
March 6, 2020
Decision date
June 25, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KRA – Catheter, Continuous Flush
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1210
Specialty
Cardiovascular

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K260771TruSelect™ 2.6 MicrocatheterKRA · Special Boston Scientific Corporation05/15/2026SE
K250794InVera Infusion DeviceKRA · Traditional Invera Medical03/12/2026SE
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K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S…KRA · Traditional Transit Scientific, LLC11/29/2023SE
K231279Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmKRA · Traditional Ablative Solutions, Inc.07/05/2023SE
K231148ScleroSafe™ 150 mm, ScleroSafe™ 350 mmKRA · Traditional Vvt Medical , Ltd.06/20/2023SE
K230957TriSalus TriNav® LV Infusion SystemKRA · Traditional Trisalus Life Sciences05/02/2023SE
K223139Wallaby 017 Micro CatheterKRA · Traditional Wallaby Medical04/25/2023SE

More from Wallaby Medical

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K252213Bendit17 MicrocatheterQJP · Special 12/03/2025SE
K203842Bendit21 MicrocatheterQJP · Traditional 04/13/2022SE
K190126Bendit2.7 Steerable MicrocatheterDQO · Traditional 08/22/2019SE

Questions and answers

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

Bendit2.7 Steerable Microcatheter (K200582) received a 510(k) decision of Substantially Equivalent on June 25, 2020, 111 days after the submission was received.

What is the product code of K200582?

The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.