EMBOTRAP III Revascularization Device
FDA 510(k) K251789 · Neuravi Limited
510(k) numberK251789
Submission
- Device name
- EMBOTRAP III Revascularization Device
- Applicant
- Neuravi Limited
Galway, IE - Received
- June 11, 2025
- Decision date
- September 25, 2025
- 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 |
| 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 |
|---|---|---|
| K233924 | EMBOGUARD Balloon Guide CatheterQJP · Special | 04/18/2024SE |
| K212340 | EMBOGUARD Balloon Guide CatheterQJP · Traditional | 12/17/2021SE |
| K212908 | EmboTrap II Revascularization Device, EMBOTRAP III Revascularization DeviceNRY · Special | 10/13/2021SE |
| K211338 | EMBOTRAP III Revascularization DeviceNRY · Traditional | 07/30/2021SE |
| K193063 | EMBOTRAP III Revascularization DeviceNRY · Traditional | 07/14/2020SE |
| K173452 | EmboTrap ll Revascularization DeviceNRY · Traditional | 05/09/2018SE |
Questions and answers
When was EMBOTRAP III Revascularization Device cleared by the FDA?
EMBOTRAP III Revascularization Device (K251789) received a 510(k) decision of Substantially Equivalent on September 25, 2025, 106 days after the submission was received.
What is the product code of K251789?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.