Cleared Traditional

Bendit2.7 Steerable Microcatheter

K190126 · Bend IT Technologies, Ltd. · Cardiovascular

Aug 2019

Decision

206d

Days

Class 2

Risk

About This 510(k) Submission

K190126 is an FDA 510(k) clearance for the Bendit2.7 Steerable Microcatheter, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Bend IT Technologies, Ltd. (Petach Tikva, IL). The FDA issued a Cleared decision on August 22, 2019, 206 days after receiving the submission on January 28, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K190126 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 28, 2019
Decision Date	August 22, 2019
Days to Decision	206 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF