Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter
FDA 510(k) K241388 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
510(k) numberK241388
Submission
- Device name
- Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Irvine, CA, US - Received
- May 15, 2024
- Decision date
- January 2, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QJP – Catheter, Percutaneous, Neurovasculature
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
To provide vascular access to the neurovasculature for interventional or diagnostic procedures
Other 510(k)s with product code QJP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262277 | 70 NeuGlide CatheterQJP · Special | Piraeus Medical, Inc. | 09/04/2026SE |
| K261176 | Zoom 4S CatheterQJP · Traditional | Imperative Care, Inc. | 08/28/2026SE |
| K254071 | p17 XR MicrocatheterQJP · Traditional | Wallaby Medical | 08/18/2026SE |
| K260199 | SLIM MicrocatheterQJP · Traditional | Balt USA, LLC | 07/13/2026SE |
| K253901 | Millipede88 Access CatheterQJP · Traditional | Perfuze, Ltd. | 07/09/2026SE |
| K261889 | Trevo Trak 21 MicrocatheterQJP · Special | Stryker Neurovascular | 07/01/2026SE |
| K261808 | ISAAC Neurovascular Navigation CatheterQJP · Special | Microvention Inc. d/b/a Terumo Neuro | 06/30/2026SE |
| K261549 | BOBBY Balloon Guide CatheterQJP · Special | MicroVention, Inc., d/b/a Terumo Neuro | 06/09/2026SE |
| K253359 | Zenith Distal Access Long SheathQJP · Traditional | Suzhou Zenith Vascular SciTech Limited | 05/22/2026SE |
| K254178 | SAYA 86 Radial Access Guide CatheterQJP · Traditional | Asahi Intecc Co., Ltd. | 05/11/2026SE |
More from Asahi Intecc Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K243418 | Riptide Aspiration Pump; Riptide Collection Canister with Intermediate TubingJCX · Special | 12/02/2024SE |
| 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 Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter cleared by the FDA?
Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter (K241388) received a 510(k) decision of Substantially Equivalent on January 2, 2025, 232 days after the submission was received.
What is the product code of K241388?
The FDA product code is QJP – Catheter, Percutaneous, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1250.