Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1210](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1210) → KRA — Catheter, Continuous Flush # KRA · Catheter, Continuous Flush _Cardiovascular · 21 CFR 870.1210 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA ## Overview - **Product Code:** KRA - **Device Name:** Catheter, Continuous Flush - **Regulation:** [21 CFR 870.1210](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1210) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 173) Showing 20 most recent of 173 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250794](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K250794.md) | InVera Infusion Device | Invera Medical | Mar 12, 2026 | SESE | | [K243534](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K243534.md) | Micro Catheter | Suzhou Zenith Vascular SciTech Limited | Jul 30, 2025 | SESE | | [K231821](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K231821.md) | XO 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, LLC | Nov 29, 2023 | SESE | | [K231279](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K231279.md) | Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm | Ablative Solutions, Inc. | Jul 5, 2023 | SESE | | [K231148](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K231148.md) | ScleroSafe™ 150 mm, ScleroSafe™ 350 mm | Vvt Medical , Ltd. | Jun 20, 2023 | SESE | | [K230957](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K230957.md) | TriSalus TriNav® LV Infusion System | Trisalus Life Sciences | May 2, 2023 | SESE | | [K223139](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K223139.md) | Wallaby 017 Micro Catheter | Wallaby Medical | Apr 25, 2023 | SESE | | [K223176](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K223176.md) | Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister | Argon Medical Devices, Inc. | Apr 10, 2023 | SESE | | [K230636](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K230636.md) | Maestro Microcatheter | Merit Medical System, Inc. | Mar 30, 2023 | SESE | | [K222679](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K222679.md) | Vericor Support Catheter | Vascupatent Medical (Shenzhen) Co., Ltd. | Nov 7, 2022 | SESE | | [K213435](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K213435.md) | MAGIC Flow-Dependent Microcatheter | Balt USA, LLC | Jul 19, 2022 | SESE | | [K213442](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K213442.md) | Extroducer Infusion Catheter System | SmartWise Sweden AB | Jun 10, 2022 | SESE | | [K214025](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K214025.md) | PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter | Medos International SARL | Apr 12, 2022 | SESE | | [K212719](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K212719.md) | Micro Catheter and Guidewire System | Suzhou Hengrui Hongyuan Medical Co., Ltd. | Apr 11, 2022 | SESE | | [K211110](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K211110.md) | Agile Devices Angler Steerable, Deflectable Microcatheter | Agile Devices, Inc. | Jan 7, 2022 | SESE | | [K210838](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K210838.md) | PROWLER SELECT PLUS; PROWLER EX | Medos International SARL | Aug 25, 2021 | SESE | | [K210339](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K210339.md) | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | Aug 2, 2021 | SESE | | [K211525](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K211525.md) | SwiftNINJA Steerable Microcatheter | Merit Medical Systems, Inc. | Jul 16, 2021 | SESE | | [K210808](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K210808.md) | Instylla Microcatheter 1.2 | Instylla, Inc. | Apr 15, 2021 | SESE | | [K210114](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K210114.md) | Rebar Micro Catheter | Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular | Feb 16, 2021 | SESE | ## Top Applicants - Micro Therapeutics, Inc. — 17 clearances - Cordis Neurovascular, Inc. — 13 clearances - Cook, Inc. — 8 clearances - Boston Scientific Corp — 7 clearances - Merit Medical Systems, Inc. — 7 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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