510(k) K141617
- Device
- CLEANERXT ROTATIONAL THROMBECTOMY SYSTEM, CLEANER15 ROTATIONAL THROMBECTOMY SYSTEM
- Applicant
- REX MEDICAL, L.P.
- 510(k) number
- K141617
- Product code
- KRA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-11-14
- Date received
- 2014-06-17
- Regulation
- 870.1210
- Classification name
- Catheter, Continuous Flush
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUSAN D GOLDSTEIN-FALK
- Address
- 55 Northern Boulbevard Great Neck NY US 11021 11021
FDA Registration Numbers#
- 1000523114
- 1721676
- 3011642792
- 3011471056
- 3004593495
- 3030481118
- 3034619061
- 2134265
- 3029444898
- 3011137372
- 3008514120
- 9616684
- 3005160949
- 1625425
- 2011171
- 3016591327
- 3002807314
- 3008700817
- 9681260
- 1048735
- 2648729
- 3014787927
- 1644312
- 3010041511
- 2020394
- 3004198398
- 1225687
- 3008114965
- 3013758550
- 2022435
- 3004859241
- 3008439199
- 3027226463
- 3015924373
- 2244478
- 3004111573
- 1000121056
- 3014687026
- 3031823122
- 3010273872
- 3014590708
- 2030624
- 3026567963
- 3007695959
- 1319211
- 3010034260
- 1724474
- 3015615738
- 2032098
- 3031976597
- 3020347218
- 3013944123
- 3017823876
- 9612164
- 1064858
- 3010220595
- 3005168196
- 3040801290
- 3016704395
- 3020256033
- 3004737415
- 3006946276
- 3014498720
- 3004832480
- 3009380063
- 3010047454
- 2124215
- 2183744
- 3019807891
- 1424778
- 3025465918
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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