Esperance pHLO Aspiration System
FDA 510(k) K251357 · Phenox, Ltd.
510(k) numberK251357
Submission
- Device name
- Esperance pHLO Aspiration System
- Applicant
- Phenox, Ltd.
Galway, IE - Received
- April 30, 2025
- Decision date
- January 15, 2026
- 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 |
|---|---|---|
| K242676 | pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy DevicePOL · Special | 02/28/2025SE |
| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | 11/12/2024SE |
| K231539 | pRESET LITE Thrombectomy DevicePOL · Traditional | 10/21/2023SE |
| K222848 | pRESET Thrombectomy DevicePOL · Traditional | 01/20/2023SE |
| K221279 | pNOVUS 21 MicrocatheterDQO · Traditional | 11/28/2022SE |
| K191687 | pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension WireDQX · Traditional | 10/09/2019SE |
Questions and answers
When was Esperance pHLO Aspiration System cleared by the FDA?
Esperance pHLO Aspiration System (K251357) received a 510(k) decision of Substantially Equivalent on January 15, 2026, 260 days after the submission was received.
What is the product code of K251357?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.