Route 92 Medical 088 Access System
FDA 510(k) K201518 · Route 92 Medical
510(k) numberK201518
Submission
- Device name
- Route 92 Medical 088 Access System
- Applicant
- Route 92 Medical
San Mateo, CA, US - Received
- June 8, 2020
- Decision date
- August 14, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K243601 | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetNRY · Traditional | 05/19/2025SE |
| K240529 | 8F Modified Sheath SystemQJP · Special | 10/02/2024SE |
| K233329 | Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing SetNRY · Special | 04/23/2024SE |
| K231583 | Route 92 Medical Full Length 054 Access SystemQJP · Special | 08/15/2023SE |
| K223530 | Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetNRY · Traditional | 04/11/2023SE |
| K222743 | Route 92 Medical Full Length 070 Access SystemQJP · Special | 10/04/2022SE |
| K210635 | Route 92 Medical Full Length 088 Access SystemQJP · Special | 07/27/2021SE |
| K203043 | Route 92 Medical 070 Access SystemQJP · Special | 11/11/2020SE |
| K200121 | Route 92 Medical 088 Access System, 110 cmQJP · Traditional | 04/18/2020SE |
| K191717 | Route 92 Medical Sheath SystemDQY · Traditional | 01/13/2020SE |
Questions and answers
When was Route 92 Medical 088 Access System cleared by the FDA?
Route 92 Medical 088 Access System (K201518) received a 510(k) decision of Substantially Equivalent on August 14, 2020, 67 days after the submission was received.
What is the product code of K201518?
The FDA product code is QJP – Catheter, Percutaneous, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1250.