FDA.report

510(k) K252213

Device
Bendit17 Microcatheter
Applicant
Bend IT Technologies, Ltd.
510(k) number
K252213
Product code
QJP
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-03
Date received
2025-07-15
Regulation
870.1250
Classification name
Catheter, Percutaneous, Neurovasculature
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Simona Beilin Nissan
Address
25 Basel St. Petach Tikva IL 4951038 4951038

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code QJP

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K260938PATH BGCCrossroads Neurovascular, Inc.2026-04-15
K253975Radical 6F Access CatheterMaduro Medical, Inc.2026-04-09
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K252297Toro 88 Superbore CatheterToro Neurovascular, Inc.2026-01-16
K251097V-DAC CatheterVesalio, Inc.2026-01-06
K251668SurfRider 13 MicrocatheterKaneka Americas Holding, Inc.2026-01-05
K251372VersaD Delivery CatheterUnity Medical, Inc.2025-10-24
K252569Carrier XL Delivery CatheterBalt USA, LLC2025-10-22
K250960DUO MicrocatheterRev Neuro, LLC2025-09-08
K251560FUBUKI XF-R Neurovascular Long SheathAsahi Intecc Co., Ltd.2025-06-20
K251240Branchor X Balloon Guide CatheterAsahi Intecc Co., Ltd.2025-06-20
K25104493 NeuFlex CatheterPiraeus Medical2025-05-23