FDA.reportPublic FDA data

510(k) K230636

Device
Maestro Microcatheter
Applicant
Merit Medical System, Inc.
510(k) number
K230636
Product code
KRA
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-30
Date received
2023-03-07
Regulation
870.1210
Classification name
Catheter, Continuous Flush
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Garry Courtney
Address
1600 W. Merit Pkwy. South Jordan UT US 84095 84095

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KRA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation2026-05-15
K250794InVera Infusion DeviceInvera Medical2026-03-12
K243534Micro CatheterSuzhou Zenith Vascular SciTech Limited2025-07-30
K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)Transit Scientific, LLC2023-11-29
K231279Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmAblative Solutions, Inc.2023-07-05
K231148ScleroSafe™ 150 mm, ScleroSafe™ 350 mmVvt Medical , Ltd.2023-06-20
K230957TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences2023-05-02
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K223176Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration CanisterArgon Medical Devices, Inc.2023-04-10
K222679Vericor Support CatheterVascupatent Medical (Shenzhen) Co., Ltd.2022-11-07
K213435MAGIC Flow-Dependent MicrocatheterBalt USA, LLC2022-07-19
K213442Extroducer Infusion Catheter SystemSmartWise Sweden AB2022-06-10
K214025PROWLER SELECT LP ES Microcatheter; PROWLER XS MicrocatheterMedos International SARL2022-04-12
K212719Micro Catheter and Guidewire SystemSuzhou Hengrui Hongyuan Medical Co., Ltd.2022-04-11
K211110Agile Devices Angler Steerable, Deflectable MicrocatheterAgile Devices, Inc.2022-01-07