Cleared Traditional

Bendit2.7 Steerable Microcatheter

K200582 · Bend IT Technologies, Ltd. · Cardiovascular
Jun 2020
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K200582 is an FDA 510(k) clearance for the Bendit2.7 Steerable Microcatheter, a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Bend IT Technologies, Ltd. (Petach Tikva, IL). The FDA issued a Cleared decision on June 25, 2020, 111 days after receiving the submission on March 6, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number K200582 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2020
Decision Date June 25, 2020
Days to Decision 111 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRA — Catheter, Continuous Flush
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1210

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