Esperance pHLO Aspiration System
The Esperance pHLO Aspiration System removes obstructing material by suction during treatment of acute ischemic stroke. It combines an aspiration catheter, tubing set and introducer sheath…
The Esperance pHLO Aspiration System removes obstructing material by suction during treatment of acute ischemic stroke. It combines an aspiration catheter, tubing set and introducer sheath with a compatible aspiration pump. Trained physicians use the system in a healthcare facility or hospital.
Its indication covers large vessel occlusion in the internal carotid, middle cerebral M1 or M2, basilar or vertebral arteries within eight hours of symptom onset. Candidates are patients unable to receive thrombolytic drug treatment or whose thrombolytic treatment has failed.
Listed Item
As part of the Esperance pHLO Aspiration System, the Esperance pHLO Aspiration Catheter with a compatible aspiration pump and the Esperance Aspiration Tubing Set is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
Catheter Construction
The flexible single channel catheter connects to the vacuum source through its proximal hub. It has a radiopaque distal marker and a lubricious hydrophilic coating. The two listed catheter models have working lengths of 125 and 135 centimetres and a 0.071 inch inner diameter.
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
Record
| Listed by | Phenox Limited, Ireland |
|---|---|
| FDA product code | NRY |
| Device type | Catheter, Thrombus Retriever |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K251357 |
| Record published | 2026-02-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Catheter length 125 to 135 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PHLO-AC-71-135 | Catheter Length 135 cm | In distribution |
| PHLO-AC-71-125 | Catheter Length 125 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Penumbra System | Penumbra Inc. | 100 |
| RED 43 | Penumbra Inc. | 18 |
| Solitaire™ X-Pack | Micro Therapeutics, Inc. | 14 |
| ACE | Penumbra Inc. | 14 |
| Raptor Aspiration Catheter | Balt USA, LLC | 13 |
| Cereglide | Cerenovus, Inc. | 13 |
| Solitaire™ | Micro Therapeutics, Inc. | 9 |
| Solitaire™ X | Micro Therapeutics, Inc. | 9 |
| RED 68 | Penumbra Inc. | 9 |
| Riptide™ | Micro Therapeutics, Inc. | 9 |
| Zoom™ Reperfusion Catheter | Imperative Care Inc. | 9 |
| CaptureTM | Micro Therapeutics, Inc. | 8 |
Showing 12 of 80. All products under Catheter, Thrombus Retriever
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251357 | 2026-01-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.