Product code KRA
- Device name
- Catheter, Continuous Flush
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1210
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253509 | TriSalus TriNav Advance Infusion System | Trisalus Life Sciences | 2026-09-21 |
| K254051 | Extroducer Infusion Catheter System | SmartWise Sweden AB | 2026-09-11 |
| K261610 | Verge™ Microcatheter | Instylla, Inc. | 2026-06-11 |
| K260771 | TruSelect™ 2.6 Microcatheter | Boston Scientific Corporation | 2026-05-15 |
| K250794 | InVera Infusion Device | Invera Medical | 2026-03-12 |
| K243534 | Micro Catheter | Suzhou Zenith Vascular SciTech Limited | 2025-07-30 |
| 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, E26-1... | Transit Scientific, LLC | 2023-11-29 |
| K231279 | Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm | Ablative Solutions, Inc. | 2023-07-05 |
| K231148 | ScleroSafe™ 150 mm, ScleroSafe™ 350 mm | Vvt Medical , Ltd. | 2023-06-20 |
| K230957 | TriSalus TriNav® LV Infusion System | Trisalus Life Sciences | 2023-05-02 |
| K223139 | Wallaby 017 Micro Catheter | Wallaby Medical | 2023-04-25 |
| 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. | 2023-04-10 |
| K230636 | Maestro Microcatheter | Merit Medical System, Inc. | 2023-03-30 |
| K222679 | Vericor Support Catheter | Vascupatent Medical (Shenzhen) Co., Ltd. | 2022-11-07 |
| K213435 | MAGIC Flow-Dependent Microcatheter | Balt USA, LLC | 2022-07-19 |
| K213442 | Extroducer Infusion Catheter System | SmartWise Sweden AB | 2022-06-10 |
| K214025 | PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter | Medos International SARL | 2022-04-12 |
| K212719 | Micro Catheter and Guidewire System | Suzhou Hengrui Hongyuan Medical Co., Ltd. | 2022-04-11 |
| K211110 | Agile Devices Angler Steerable, Deflectable Microcatheter | Agile Devices, Inc. | 2022-01-07 |
| K210838 | PROWLER SELECT PLUS; PROWLER EX | Medos International SARL | 2021-08-25 |
| K210339 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2021-08-02 |
| K211525 | SwiftNINJA Steerable Microcatheter | Merit Medical Systems, Inc. | 2021-07-16 |
| K210808 | Instylla Microcatheter 1.2 | Instylla, Inc. | 2021-04-15 |
| K210114 | Rebar Micro Catheter | Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular | 2021-02-16 |
| K202366 | MAGIC Infusion Catheter | Balt USA, LLC | 2021-01-29 |
| K202318 | Marathon Flow Directed Micro Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-09-14 |
| K193082 | Fountain ValveTip Infusion Catheter | Merit Medical Systems, Inc. | 2020-08-07 |
| K201907 | ClariVein IC | Merit Medical Systems, Inc. | 2020-08-06 |
| K201792 | TRUSELECT Microcatheter | Boston Scientific Corporation | 2020-07-28 |
| K200582 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2020-06-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850044140022 | Helo Max Thrombectomy System | Endovascular Engineering, Inc. | 2026-09-29 |
| 00857136004415 | TriNav Advance Infusion System | SUREFIRE MEDICAL, INC. | 2026-09-24 |
| 00857136004408 | TriNav Advance Infusion System | SUREFIRE MEDICAL, INC. | 2026-09-24 |
| 00857136004392 | TriNav Advance Infusion System | SUREFIRE MEDICAL, INC. | 2026-09-24 |
| 00857136004293 | TriNav Advance Infusion System | SUREFIRE MEDICAL, INC. | 2026-09-24 |
| 00885403542667 | TRUWAVE | Becton, Dickinson And Company | 2026-09-05 |
| B090E20130B0 | XO Cath | Zien Medical Technologies, LLC | 2024-04-30 |
| B0902P0130S0 | Knight Microcatheter | Zien Medical Technologies, LLC | 2024-04-30 |
| B0902P0130B0 | Knight Microcatheter | Zien Medical Technologies, LLC | 2024-04-30 |
| B090E20130S0 | XO Cath | Zien Medical Technologies, LLC | 2024-04-30 |
| 00810123710522 | Triever20 Curve | Inari Medical, Inc. | 2023-12-15 |
| 00812339030319 | Pounce Venous Thrombectomy System | Surmodics, Inc. | 2023-10-27 |
| 00850291007277 | ClotTriever XL Catheter | Inari Medical, Inc. | 2023-05-09 |
| 00850291007376 | Artix™ AX | Inari Medical, Inc. | 2023-04-24 |
| 00812339030302 | Pounce™ Venous Thrombectomy System | Surmodics, Inc. | 2022-06-22 |
| 00763000399665 | PhenomTM 17 Catheter | Micro Therapeutics, Inc. | 2021-04-26 |
| 00763000399733 | PhenomTM Plus Catheter | Micro Therapeutics, Inc. | 2021-04-26 |
| 00763000399719 | PhenomTM 27 Catheter | Micro Therapeutics, Inc. | 2021-04-26 |
| 00763000399702 | PhenomTM 27 Catheter | Micro Therapeutics, Inc. | 2021-04-26 |
| 00763000399689 | PhenomTM 21 Catheter | Micro Therapeutics, Inc. | 2021-04-26 |
| 00763000399672 | PhenomTM 17 Catheter | Micro Therapeutics, Inc. | 2021-04-26 |
| 00763000399658 | PhenomTM 17 Catheter | Micro Therapeutics, Inc. | 2021-04-26 |
| 00763000399641 | PhenomTM 17 Catheter | Micro Therapeutics, Inc. | 2021-04-26 |
| 00814584020381 | Phenom™ Catheter | CATHERA, INC. | 2016-10-20 |
| 00814584020398 | Phenom™ Catheter | CATHERA, INC. | 2016-10-20 |
| 00814584020435 | Phenom™ Catheter | CATHERA, INC. | 2016-10-20 |
| 00814584020442 | Phenom™ Catheter | CATHERA, INC. | 2016-10-20 |
| 00850291007000 | FlowTriever Catheter, S | Inari Medical, Inc. | 2016-09-15 |
| 00850291007055 | FlowTriever Catheter, XL | Inari Medical, Inc. | 2016-09-15 |
| 00850291007017 | FlowTriever Catheter, M | Inari Medical, Inc. | 2016-09-15 |