510(k) K093750
- Device
- ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA
- Applicant
- EV3 INC
- 510(k) number
- K093750
- Product code
- KRA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-12-09
- Date received
- 2009-12-07
- 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
- No
Applicant Contact#
- Contact
- Laura Heaton
- Address
- 9775 Toledo Way Irvine CA US 92618 92618
FDA Registration Numbers#
- 3012543881
- 9615817
- 3032916632
- 3027395815
- 2183870
- 1018233
- 2134265
- 3043337628
- 3021067373
- 3013391155
- 1625425
- 2011171
- 3000126629
- 2648729
- 3012307300
- 3010041511
- 3007156625
- 3009756153
- 3015924373
- 9612501
- 3012536737
- 3004111573
- 3014779787
- 1000121056
- 3015453963
- 3031823122
- 3004415014
- 3008824097
- 2030624
- 1724474
- 3033589330
- 8010026
- 3015489145
- 2183319
- 2015691
- 8023054
- 3010220595
- 1064858
- 3040801290
- 3009500972
- 2124215
- 3012497308
- 2183744
- 3017208642
- 9617594
- 3008307705
- 3008514120
- 3006550224
- 3005160949
- 9616662
- 1928237
- 3010079067
- 3014787927
- 3015309643
- 3031240343
- 1319639
- 2024311
- 3038791046
- 3008853977
- 3008264254
- 3014162263
- 3014211783
- 1319211
- 3010273872
- 1820334
- 3007695959
- 3016927279
- 3031976597
- 9616567
- 3017823876
- 3013134719
- 3010665433
- 3020256033
- 3006946276
- 3023167283
- 3030733800
- 3010047454
- 1713468
- 3010334444
- 9612051
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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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