Apro 70 Catheter
Apro 70 Catheter removes thrombus by aspiration in selected patients with acute ischemic stroke from intracranial large-vessel occlusion. It is used with an aspiration pump and Alembic…
Apro 70 Catheter removes thrombus by aspiration in selected patients with acute ischemic stroke from intracranial large-vessel occlusion. It is used with an aspiration pump and Alembic tubing within eight hours of symptom onset when intravenous t-PA is unsuitable or unsuccessful.
The single-lumen catheter has braid and coil reinforcement, a hydrophilic distal shaft and a radiopaque distal marker. It advances over a neurovascular guidewire through a guide catheter or long femoral sheath under fluoroscopy.
Access and Aspiration
Lengths are 125, 132 and 135 cm. The tubing connects to a pump meeting specified performance requirements and includes an on/off flow-control valve. Indicated vessels include the internal carotid, M1 and M2 middle cerebral, basilar and vertebral arteries.
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) | K223545 |
| Record published | 2023-04-27 |
| Record revised | 2023-06-07 (version 2) |
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 |
| Storage | Special storage condition: Store in a dry place |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| APRO-70-135 | In distribution | |
| APRO-70-132 | In distribution | |
| FG-01016-N32 | In distribution | |
| APRO-70-125 | 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.