Apro 55 Catheter
The APRO 55 Catheter aspirates clot from intracranial vessels during treatment of acute ischemic stroke. It is used with an aspiration pump and Alembic Aspiration Tubing within eight hours…
The APRO 55 Catheter aspirates clot from intracranial vessels during treatment of acute ischemic stroke. It is used with an aspiration pump and Alembic Aspiration Tubing within eight hours of symptom onset. Candidates are patients unable to receive intravenous tissue plasminogen activator or whose treatment with it has failed.
The reinforced single channel catheter advances over a neurovascular guidewire through a guide catheter or long femoral sheath. A hydrophilic distal surface supports navigation, and a radiopaque tip marker allows fluoroscopic positioning. The pump applies suction through the catheter to the clot.
Vessel and Length Scope
The stated vessels are the internal carotid, middle cerebral M1 and M2, basilar and vertebral arteries. The catheter is available in 125 and 137 centimetre lengths and is supplied with an introducer sheath.
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 | Alembic LLC, United States |
|---|---|
| FDA product code | NRY |
| Device type | Catheter, Thrombus Retriever |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K232971 |
| Record published | 2024-04-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| APRO-55-137 | In distribution | |
| APRO-55-125 | 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 |
|---|---|
| K262391 | 2026-08-12 |
| K251015 | 2025-04-30 |
| K250958 | 2025-04-28 |
| K243287 | 2025-02-24 |
| K232971 | 2024-02-29 |
| K230695 | 2023-04-10 |
| K223545 | 2023-02-17 |
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.