MV Flow Aspiration Pump (MVFLOWPMP01)
FDA 510(k) K243638 · Microvention
510(k) numberK243638
Submission
- Device name
- MV Flow Aspiration Pump (MVFLOWPMP01)
- Applicant
- Microvention
Aliso Viejo, CA, US - Received
- November 25, 2024
- Decision date
- June 13, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code JCX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250964 | Protable Phlegm Suction Unit (JMA D01)JCX · Traditional | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 05/11/2026SE |
| K251111 | CaryJCX · Traditional | Excitus AS | 05/07/2025SE |
| K243418 | Riptide Aspiration Pump; Riptide Collection Canister with Intermediate TubingJCX · Special | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 12/02/2024SE |
| K233428 | Easycess Aspiration PumpJCX · Traditional | Guangzhou Easycess Medical Co.,Ltd | 11/03/2023SE |
| K222552 | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen…JCX · Traditional | Stryker Instruments | 12/09/2022SE |
| K182950 | Acare Suction UnitJCX · Traditional | Acare Technology Co., Ltd. | 08/23/2019SE |
| K190789 | IntelliCartTM SystemJCX · Special | Dornoch Medical Systems | 04/24/2019SE |
| K190105 | ZOOM Aspiration PumpJCX · Special | Taiwan Biomaterial Co., Ltd. | 02/21/2019SE |
| K180115 | TWBM PumpJCX · Traditional | Taiwan Biomaterial Co., Ltd. | 07/24/2018SE |
| K181398 | DV-300 AspiratorJCX · Traditional | Ding Hwa Co., Ltd. | 07/23/2018SE |
More from Ding Hwa Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K232542 | Wedge XL Delivery CatheterQJP · Traditional | 05/16/2024SE |
| K230775 | SOFIA EX Intracranial Support CatheterQJP · Traditional | 09/14/2023SE |
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)NTE · Traditional | 04/27/2023SE |
| K222115 | ISAAC Neurovascular Navigation CatheterDQY · Traditional | 01/10/2023SE |
| K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)KRD · Traditional | 12/21/2022SE |
| K214024 | SOFIA 88 CatheterDQY · Traditional | 09/12/2022SE |
| K211120 | ERIC Retrieval DeviceNRY · Traditional | 03/31/2022SE |
| K193607 | BOBBY Balloon Guide CatheterDQY · Traditional | 07/21/2020SE |
| K201487 | Traxcess 7 Mini GuidewireMOF · Special | 07/02/2020SE |
| K200547 | Traxcess 14 SELECT GuidewireMOF · Special | 04/16/2020SE |
Questions and answers
When was MV Flow Aspiration Pump (MVFLOWPMP01) cleared by the FDA?
MV Flow Aspiration Pump (MVFLOWPMP01) (K243638) received a 510(k) decision of Substantially Equivalent on June 13, 2025, 200 days after the submission was received.
What is the product code of K243638?
The FDA product code is JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 878.4780.