Apro 70 Swift Catheter
The APRO 70 Swift Catheter removes thrombus by aspiration during treatment of acute ischemic stroke. It is used with an aspiration pump and Alembic Aspiration Tubing in specified…
The APRO 70 Swift Catheter removes thrombus by aspiration during treatment of acute ischemic stroke. It is used with an aspiration pump and Alembic Aspiration Tubing in specified intracranial large vessels within eight hours of symptom onset, for patients ineligible for or unsuccessful with thrombolytic drug therapy.
The single-lumen catheter is reinforced with braid and coil and is advanced over a neurovascular guidewire under fluoroscopy. Its distal shaft has a hydrophilic coating, and a radiopaque distal marker assists positioning near the clot.
System and Vessel Scope
The pump must meet the specified performance parameters and connects through Alembic tubing with a flow-control valve. The indication covers internal carotid, M1 and M2 middle cerebral, basilar and vertebral arteries. Catheter lengths include 125, 132 and 135 cm.
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 |
| Storage | Special storage condition: Store in a dry place |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG-02133-132-AC | In distribution | |
| FG-02133-135-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.