Millipede System
FDA 510(k) K262399 · Perfuze, Ltd.
510(k) numberK262399
Submission
- Device name
- Millipede System
- Applicant
- Perfuze, Ltd.
Galway, IE - Received
- July 14, 2026
- Decision date
- August 12, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K251357 | Esperance pHLO Aspiration SystemNRY · Traditional | Phenox, Ltd. | 01/15/2026SE |
More from Phenox, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253901 | Millipede88 Access CatheterQJP · Traditional | 07/09/2026SE |
| K253590 | Millipede SystemNRY · Traditional | 03/16/2026SE |
| K252392 | Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetNRY · Special | 08/29/2025SE |
| K250012 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetNRY · Special | 02/26/2025SE |
| K240711 | Zipline Access CatheterQJP · Traditional | 10/17/2024SE |
| K242504 | Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration…NRY · Special | 09/20/2024SE |
| K233648 | Millipede 088 Access CatheterQJP · Special | 12/14/2023SE |
| K232524 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetNRY · Traditional | 10/18/2023SE |
| K231802 | Millipede 088 Access CatheterQJP · Special | 09/19/2023SE |
| K214048 | Millipede 088 Access CatheterQJP · Traditional | 09/20/2022SE |
Questions and answers
When was Millipede System cleared by the FDA?
Millipede System (K262399) received a 510(k) decision of Substantially Equivalent on August 12, 2026, 29 days after the submission was received.
What is the product code of K262399?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.