510(k) K223176
- Device
- 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
- Applicant
- Argon Medical Devices, Inc.
- 510(k) number
- K223176
- Product code
- KRA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-04-10
- Date received
- 2022-10-11
- 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
- Ana Jimenez-Hughes
- Address
- 1445 Flat Creek Rd. Athens TX US 75751 75751
FDA Registration Numbers#
- 3031240343
- 3006950086
- 3014758755
- 1000393132
- 2648045
- 3009500972
- 8020616
- 3033589330
- 3032916632
- 2134265
- 9616684
- 3002807314
- 2024311
- 3013858269
- 2022435
- 1721676
- 3008264254
- 3014162263
- 9616662
- 3006550224
- 3011137372
- 3002806337
- 3008824097
- 3004142795
- 3016927279
- 3003120897
- 3020347218
- 3006946276
- 3012497308
- 9616567
- 3023167283
- 3008114965
- 8010026
- 3017208642
- 2011171
- 3007695959
- 3008881809
- 3009546466
- 2183744
- 3013134719
- 3030733800
- 1220477
- 3012543881
- 9681834
- 3013556777
- 3017210488
- 3016948450
- 3013391155
- 3019525998
- 3014211783
- 3010421104
- 1721504
- 2032112
- 1724474
- 2183870
- 1000121056
- 9615817
- 3040099838
- 1018233
- 3013557562
- 3014590708
- 3015924373
- 1064858
- 1220948
- 9617594
- 3010079067
- 3010041511
- 3008514120
- 1928237
- 2134812
- 2124215
- 1000523114
- 3008853977
- 3009380063
- 1282497
- 2015691
- 3020256033
- 3027395815
- 1225687
Source Documents#
Other 510(k) Records For Product Code KRA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,) | 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 |
| 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 |