Bendit21 Microcatheter

FDA 510(k) K203842 · Bend IT Technologies, Ltd.

Substantially Equivalent

510(k) numberK203842

Submission

Device name
Bendit21 Microcatheter
Applicant
Bend IT Technologies, Ltd.
Petach Tikva, IL
Received
December 31, 2020
Decision date
April 13, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QJP – Catheter, Percutaneous, Neurovasculature
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Specialty
Cardiovascular

To provide vascular access to the neurovasculature for interventional or diagnostic procedures

Other 510(k)s with product code QJP

510(k)DeviceApplicantDecision
K26227770 NeuGlide CatheterQJP · Special Piraeus Medical, Inc.09/04/2026SE
K261176Zoom 4S CatheterQJP · Traditional Imperative Care, Inc.08/28/2026SE
K254071p17 XR MicrocatheterQJP · Traditional Wallaby Medical08/18/2026SE
K260199SLIM MicrocatheterQJP · Traditional Balt USA, LLC07/13/2026SE
K253901Millipede88 Access CatheterQJP · Traditional Perfuze, Ltd.07/09/2026SE
K261889Trevo Trak 21 MicrocatheterQJP · Special Stryker Neurovascular07/01/2026SE
K261808ISAAC Neurovascular Navigation CatheterQJP · Special Microvention Inc. d/b/a Terumo Neuro06/30/2026SE
K261549BOBBY Balloon Guide CatheterQJP · Special MicroVention, Inc., d/b/a Terumo Neuro06/09/2026SE
K253359Zenith Distal Access Long SheathQJP · Traditional Suzhou Zenith Vascular SciTech Limited05/22/2026SE
K254178SAYA 86 Radial Access Guide CatheterQJP · Traditional Asahi Intecc Co., Ltd.05/11/2026SE

More from Asahi Intecc Co., Ltd.

510(k)DeviceDecision
K252213Bendit17 MicrocatheterQJP · Special 12/03/2025SE
K200582Bendit2.7 Steerable MicrocatheterKRA · Traditional 06/25/2020SE
K190126Bendit2.7 Steerable MicrocatheterDQO · Traditional 08/22/2019SE

Questions and answers

When was Bendit21 Microcatheter cleared by the FDA?

Bendit21 Microcatheter (K203842) received a 510(k) decision of Substantially Equivalent on April 13, 2022, 468 days after the submission was received.

What is the product code of K203842?

The FDA product code is QJP – Catheter, Percutaneous, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1250.