Cleared Traditional

Bendit21 Microcatheter

K203842 · Bend IT Technologies, Ltd. · Neurology

Apr 2022

Decision

468d

Days

Class 2

Risk

About This 510(k) Submission

K203842 is an FDA 510(k) clearance for the Bendit21 Microcatheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Bend IT Technologies, Ltd. (Petach Tikva, IL). The FDA issued a Cleared decision on April 13, 2022, 468 days after receiving the submission on December 31, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K203842 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 31, 2020
Decision Date	April 13, 2022
Days to Decision	468 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	QJP — Catheter, Percutaneous, Neurovasculature
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures