KRA · Catheter, Continuous Flush
Cardiovascular · 21 CFR 870.1210 · Class 2
Overview
| Product Code | KRA |
|---|---|
| Device Name | Catheter, Continuous Flush |
| Regulation | 21 CFR 870.1210 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | InVera Infusion Device | Invera Medical | Mar 12, 2026 | SESE |
| K243534 | Micro Catheter | Suzhou Zenith Vascular SciTech Limited | Jul 30, 2025 | SESE |
| K231821 | 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 | Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm | Ablative Solutions, Inc. | Jul 5, 2023 | SESE |
| K231148 | ScleroSafe 150 mm, ScleroSafe 350 mm | Vvt Medical , Ltd. | Jun 20, 2023 | SESE |
| K230957 | TriSalus TriNav® LV Infusion System | Trisalus Life Sciences | May 2, 2023 | SESE |
| K223139 | Wallaby 017 Micro Catheter | Wallaby Medical | Apr 25, 2023 | SESE |
| K223176 | 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 | Maestro Microcatheter | Merit Medical System, Inc. | Mar 30, 2023 | SESE |
| K222679 | Vericor Support Catheter | Vascupatent Medical (Shenzhen) Co., Ltd. | Nov 7, 2022 | SESE |
| K213435 | MAGIC Flow-Dependent Microcatheter | Balt USA, LLC | Jul 19, 2022 | SESE |
| K213442 | Extroducer Infusion Catheter System | SmartWise Sweden AB | Jun 10, 2022 | SESE |
| K214025 | PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter | Medos International SARL | Apr 12, 2022 | SESE |
| K212719 | Micro Catheter and Guidewire System | Suzhou Hengrui Hongyuan Medical Co., Ltd. | Apr 11, 2022 | SESE |
| K211110 | Agile Devices Angler Steerable, Deflectable Microcatheter | Agile Devices, Inc. | Jan 7, 2022 | SESE |
| K210838 | PROWLER SELECT PLUS; PROWLER EX | Medos International SARL | Aug 25, 2021 | SESE |
| K210339 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | Aug 2, 2021 | SESE |
| K211525 | SwiftNINJA Steerable Microcatheter | Merit Medical Systems, Inc. | Jul 16, 2021 | SESE |
| K210808 | Instylla Microcatheter 1.2 | Instylla, Inc. | Apr 15, 2021 | SESE |
| K210114 | 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
