Bendit21 Microcatheter— 510(k) K203842

Name: FDA 510(k) clearance K203842
Creator: U.S. Food and Drug Administration
Published: 2022-04-13

Substantially Equivalent

Bend IT Technologies, Ltd.

FDA 510(k) clearance K203842 for Bendit21 Microcatheter, Substantially Equivalent on 2022-04-13. Applicant: Bend IT Technologies, Ltd.. Device class: 2.

Clearance details

Applicant: Bend IT Technologies, Ltd.
Product code: Code QJP
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2020-12-31
Decision date: 2022-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petach Tikva, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code QJP

view all

K262277 — 70 NeuGlide Catheter2026-09-04
K261176 — Zoom 4S Catheter2026-08-28
K254071 — p17 XR Microcatheter2026-08-18
K260199 — SLIM Microcatheter2026-07-13
K253901 — Millipede88 Access Catheter2026-07-09

More clearances from Bend IT Technologies, Ltd.

view all

K252213 — Bendit17 Microcatheter2025-12-03
K200582 — Bendit2.7 Steerable Microcatheter2020-06-25
K190126 — Bendit2.7 Steerable Microcatheter2019-08-22

Adverse events under product code QJP

product code QJP

Death: 43
Injury: 233
Malfunction: 1,010
Total: 1,286

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.