510(k) K090759
- Device
- BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM
- Applicant
- BIODRAIN MEDICAL, INC.
- 510(k) number
- K090759
- Product code
- JCX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-04-01
- Date received
- 2009-03-23
- Regulation
- 878.4780
- Classification name
- Apparatus, Suction, Ward Use, Portable, Ac-powered
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- CHAD RUWE
- Address
- 2060 Centre Pt.e Blvd. Suite 7 Mendota Heights MN US 55120 55120
FDA Registration Numbers#
- 3014810929
- 3036756245
- 2225311
- 3015967359
- 3003144120
- 3013666218
- 3016678045
- 3015207155
- 9611102
- 2249651
- 9611665
- 2022724
- 3007682555
- 3030733800
- 3012316249
- 3003542872
- 3006789357
- 1043214
- 2320762
- 3011418975
- 3003803075
- 1526350
- 2246552
- 3004993040
- 3006535925
- 1317202
- 3021009035
- 3004112621
- 2431273
- 3015550451
- 3014590707
- 3021244152
- 1055236
- 3008363932
- 9616843
- 3010079067
- 3005168196
- 3013758550
- 3006446479
- 3033509898
- 3016591327
- 3003627840
- 3010834934
- 8022210
- 3008220943
- 3006395447
- 2029214
- 3004598644
- 3007997036
- 2031894
- 3003595343
- 3007127244
- 2515872
- 3012497308
- 3032391
- 3006142527
- 3012494290
- 1054241
- 3015615738
- 1924066
- 3025603301
- 3013556777
Source Documents#
Other 510(k) Records For Product Code JCX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250964 | Protable Phlegm Suction Unit (JMA D01) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2026-05-11 |
| K243638 | MV Flow Aspiration Pump (MVFLOWPMP01) | Microvention | 2025-06-13 |
| K251111 | Cary | Excitus AS | 2025-05-07 |
| K243418 | Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2024-12-02 |
| K233428 | Easycess Aspiration Pump | Guangzhou Easycess Medical Co.,Ltd | 2023-11-03 |
| K222552 | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) | Stryker Instruments | 2022-12-09 |
| K182950 | Acare Suction Unit | Acare Technology Co., Ltd. | 2019-08-23 |
| K190789 | IntelliCartTM System | Dornoch Medical Systems | 2019-04-24 |
| K190105 | ZOOM Aspiration Pump | Taiwan Biomaterial Co., Ltd. | 2019-02-21 |
| K180115 | TWBM Pump | Taiwan Biomaterial Co., Ltd. | 2018-07-24 |
| K181398 | DV-300 Aspirator | Ding Hwa Co., Ltd. | 2018-07-23 |
| K172481 | IntelliCart System | Dornoch Medical Systems | 2017-09-14 |
| K161358 | Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds | Surgical Instrument Service and Savings, Inc. | 2017-08-03 |
| K162421 | IntelliCartTM System | Dornoch Medical Systems | 2016-12-21 |
| K153407 | Stryker Neptune 3 Waste Management System | Stryker Corporation | 2016-04-25 |
Legacy Summary#
summary
FDA Review#
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