KRA — Catheter, Continuous Flush Class II

FDA Device Classification

Classification Details

Product Code
KRA
Device Class
Class II
Regulation Number
870.1210
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250794invera medicalInVera Infusion DeviceMarch 12, 2026
K243534suzhou zenith vascular scitech limitedMicro CatheterJuly 30, 2025
K231821transit scientificXO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E2November 29, 2023
K231279ablative solutionsPeregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-July 5, 2023
K231148vvt medicalScleroSafe™ 150 mm, ScleroSafe™ 350 mmJune 20, 2023
K230957trisalus life sciencesTriSalus TriNav® LV Infusion SystemMay 2, 2023
K223139wallaby medicalWallaby 017 Micro CatheterApril 25, 2023
K223176argon medical devicesCleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner PlApril 10, 2023
K230636merit medical systemMaestro MicrocatheterMarch 30, 2023
K222679vascupatent medical (shenzhen) coVericor Support CatheterNovember 7, 2022
K213435balt usaMAGIC Flow-Dependent MicrocatheterJuly 19, 2022
K213442smartwise swedenExtroducer Infusion Catheter SystemJune 10, 2022
K214025medos international sarlPROWLER SELECT LP ES Microcatheter; PROWLER XS MicrocatheterApril 12, 2022
K212719suzhou hengrui hongyuan medical coMicro Catheter and Guidewire SystemApril 11, 2022
K211110agile devicesAgile Devices Angler Steerable, Deflectable MicrocatheterJanuary 7, 2022
K210838medos international sarlPROWLER SELECT PLUS; PROWLER EXAugust 25, 2021
K210339mercator medsystemsBullfrog Micro-Infusion DeviceAugust 2, 2021
K211525merit medical systemsSwiftNINJA Steerable MicrocatheterJuly 16, 2021
K210808instyllaInstylla Microcatheter 1.2April 15, 2021
K210114micro therapeuatics, inc. d/b/a ev3 neurovascularRebar Micro CatheterFebruary 16, 2021