Apro 70 SwiftCatheter
The APRO 70 Swift Catheter removes thrombus by aspiration in acute ischemic stroke from intracranial large-vessel occlusion. Its use is limited to eight hours after symptom onset in…
The APRO 70 Swift Catheter removes thrombus by aspiration in acute ischemic stroke from intracranial large-vessel occlusion. Its use is limited to eight hours after symptom onset in patients ineligible for, or unsuccessfully treated with, thrombolytic drugs. Target vessels include the internal carotid, middle cerebral M1/M2, basilar and vertebral arteries.
The single-lumen catheter carries suction from a pump to the clot. It is advanced over a neurovascular guidewire through a guide catheter or long femoral sheath under fluoroscopy. A hydrophilic distal coating aids navigation, while a distal radiopaque marker shows its position.
Aspiration Connection
The catheter connects to a pump meeting specified performance parameters through Alembic Aspiration Tubing and a compatible canister and accessory kit. A tubing valve switches aspiration flow on or off.
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) | K243287 |
| Record published | 2025-03-04 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG-02133-125-AC | 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.