Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing
FDA 510(k) K243418 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
510(k) numberK243418
Submission
- Device name
- Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Irvine, CA, US - Received
- November 4, 2024
- Decision date
- December 2, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K243638 | MV Flow Aspiration Pump (MVFLOWPMP01)JCX · Traditional | Microvention | 06/13/2025SE |
| K251111 | CaryJCX · Traditional | Excitus AS | 05/07/2025SE |
| 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 |
|---|---|---|
| K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…QJP · Special | 01/02/2025SE |
| K243080 | Riptide Aspiration SystemNRY · Special | 10/29/2024SE |
| K211990 | Rist 071 Radial Access Guide CatheterDQY · Special | 07/27/2021SE |
| K203432 | Axium Detachable Coil; Axium Prime Detachable CoilHCG · Traditional | 07/07/2021SE |
| K203358 | Solitaire X Revascularization DevicePOL · Traditional | 03/01/2021SE |
| K202850 | Concerto Versa, Detachable CoilKRD · Traditional | 02/09/2021SE |
| K193576 | Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device…POL · Traditional | 11/20/2020SE |
| K202318 | Marathon Flow Directed Micro CatheterKRA · Special | 09/14/2020SE |
| K201690 | Mirage Hydrophilic Guidewire; X-pedion Hydrophilic GuidewireDQX · Special | 07/21/2020SE |
| K201689 | Riptide Aspiration SystemNRY · Special | 07/21/2020SE |
Questions and answers
When was Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing cleared by the FDA?
Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing (K243418) received a 510(k) decision of Substantially Equivalent on December 2, 2024, 28 days after the submission was received.
What is the product code of K243418?
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.