510(k) K230636
- Device
- Maestro Microcatheter
- Applicant
- Merit Medical System, Inc.
- 510(k) number
- K230636
- Product code
- KRA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-30
- Date received
- 2023-03-07
- 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
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Garry Courtney
- Address
- 1600 W. Merit Pkwy. South Jordan UT US 84095 84095
FDA Registration Numbers
- 3010665433
- 3013858269
- 3043337628
- 3014687026
- 3031240343
- 9616662
- 3016927279
- 3008307705
- 2183870
- 3010909876
- 3015453963
- 2183744
- 3012536737
- 1644312
- 2134265
- 3012497308
- 1718873
- 3015550451
- 3013557562
- 2246552
- 3017823876
- 3014758755
- 9616684
- 1225687
- 1721676
- 1820334
- 3033589330
- 3006950086
- 3012307300
- 3010079067
- 1064858
- 3017210488
- 3017636737
- 3002807314
- 3007628272
- 1018233
- 3014644549
- 3038791046
- 3008881809
- 3030733800
- 1625425
- 3008514120
- 3012543881
- 3015489145
- 3013134719
- 3027395815
- 2648729
- 9615817
- 3020256033
- 3015151147
- 1713468
- 3013391155
- 3013556777
- 3007695959
- 1220948
- 1928237
- 1000393132
- 2531321
- 2183319
- 1724474
- 3021067373
- 1319639
- 3005160949
- 3023167283
- 3004142795
- 3003120897
- 3030481118
- 3010047454
- 3000126629
- 2030624
- 3005941719
- 3007156625
- 3015924373
- 9612501
- 2032112
- 1000523114
- 3026567963
- 9617601
- 3016948450
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00884450478189 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-07-26 |
| 00884450742747 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-07-23 |
| 00884450478295 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-06-22 |
| 00884450478103 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-06-12 |
| 00884450742723 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-06-11 |
| 00884450786246 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-06-04 |
| 00884450478097 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-05-25 |
| 00884450478028 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-05-14 |
| 00884450478011 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-05-08 |
| 00884450478127 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-05-03 |
| 00884450743041 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-04-26 |
| 00884450743003 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-04-26 |
| 00884450478172 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-04-24 |
| 00884450742945 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-04-24 |
| 00884450478240 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-04-18 |
| 00884450478196 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-04-17 |
| 00884450478264 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-04-16 |
| 00884450478288 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-04-16 |
| 00884450477960 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-04-13 |
| 00884450477977 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-04-10 |
| 00884450478080 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-04-10 |
| 00884450742730 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-04-04 |
| 00884450742716 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-04-04 |
| 00884450786239 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-04-03 |
| 00884450478219 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-04-02 |
| 00884450743010 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-03-29 |
| 00884450477984 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-03-27 |
| 00884450478158 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-03-23 |
| 00884450478257 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-03-23 |
| 00884450478233 | Merit Maestro® | Merit Medical Systems, Inc. | 2024-03-22 |
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 |
| 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 |
| 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 |