FDA.report

510(k) K254223

Device
Next Generation 088 Catheter
Applicant
Balt USA, LLC
510(k) number
K254223
Product code
QJP
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-16
Date received
2025-12-29
Regulation
870.1250
Classification name
Catheter, Percutaneous, Neurovasculature
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Subha Elango
Address
29 Parker Irvine CA US 92618 92618

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

510(k)DeviceApplicantDecision date
K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd.2026-05-11
K254046BosCATH Support CatheterSonorous NV, Inc.2026-04-21
K260938PATH BGCCrossroads Neurovascular, Inc.2026-04-15
K253975Radical 6F Access CatheterMaduro Medical, Inc.2026-04-09
K253032AXS Lift Intracranial Base CatheterStryker Neurovascular2026-02-11
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
K252213Bendit17 MicrocatheterBend IT Technologies, Ltd.2025-12-03
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