Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
FDA 510(k) K243601 · Route 92 Medical, Inc.
510(k) numberK243601
Submission
- Device name
- Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
- Applicant
- Route 92 Medical, Inc.
San Mateo, CA, US - Received
- November 21, 2024
- Decision date
- May 19, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NRY – Catheter, Thrombus Retriever
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
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| K260617 | Tigertriever 13 Ultra Revascularization DeviceNRY · Traditional | Rapid Medical Ltd. | 08/28/2026SE |
| K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setNRY · Special | CERENOVUS, Inc. | 08/13/2026SE |
| K262399 | Millipede SystemNRY · Special | Perfuze, Ltd. | 08/12/2026SE |
| K262391 | APRO 35 Swift Catheter and Alembic Aspiration TubingNRY · Special | Alembic, LLC | 08/12/2026SE |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter)NRY · Traditional | Scientia Vascular, Inc. | 07/16/2026SE |
| K250690 | Penumbra System (Thunderbolt Aspiration Tubing)NRY · Traditional | Penumbra, Inc. | 06/10/2026SE |
| K252707 | Zenith Aspiration Catheter; Disposable Aspiration Tubing SetNRY · Traditional | Suzhou Zenith Vascular SciTech Limited | 05/20/2026SE |
| K254276 | Lynx Aspiration Catheter SystemNRY · Traditional | QApel Medical, Inc. | 05/07/2026SE |
| K253590 | Millipede SystemNRY · Traditional | Perfuze, Ltd. | 03/16/2026SE |
| K253062 | Tigertriever 25 Revascularization DeviceNRY · Traditional | Rapid Medical Ltd. | 03/12/2026SE |
More from Rapid Medical Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K201518 | Route 92 Medical 088 Access SystemQJP · Traditional | 08/14/2020SE |
| 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 HiPoint Reperfusion System and Aspiration Tubing Set cleared by the FDA?
Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set (K243601) received a 510(k) decision of Substantially Equivalent on May 19, 2025, 179 days after the submission was received.
What is the product code of K243601?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.