Cleared Traditional

Bendit2.7 Steerable Microcatheter (K200582) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K200582 is an FDA 510(k) clearance for the Bendit2.7 Steerable Microcatheter. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Bend IT Technologies, Ltd. (Petach Tikva, IL). The FDA issued a Cleared decision on June 25, 2020 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Bend IT Technologies, Ltd. devices

Submission Details

510(k) Number K200582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 125d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Heyer Regulatory Solutions, LLC
Sheila Hemeon-Heyer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KRA Catheter, Continuous Flush

All 67
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K200582.
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