Apro 70 Swift Catheter
The APRO 70 Swift Catheter provides a passage for inserting and guiding appropriately sized interventional devices into selected peripheral or neurovascular vessels. It can also act as a…
The APRO 70 Swift Catheter provides a passage for inserting and guiding appropriately sized interventional devices into selected peripheral or neurovascular vessels. It can also act as a conduit for retrieval devices during an intravascular procedure.
The single-lumen shaft is reinforced with braid and coil. A hydrophilic distal coating supports navigation, and a radiopaque tip marker allows the tip to be seen under fluoroscopy. The catheter advances over a guidewire through a guide catheter or sheath.
Catheter Configuration
The straight catheter has a 0.070-inch inner diameter and is supplied with an introducer sheath. It is ethylene-oxide sterilized and intended for a single use.
Who Else Makes It
Concentrated in Shanghai (4), 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 |
| Shanghai Heartcare Medical Technology Corporation Limited | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Alembic LLC, United States |
|---|---|
| FDA product code | QJP |
| Device type | Catheter, Percutaneous, Neurovasculature |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K243297 |
| 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-02133-132-IC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Saya 86 | Asahi Intecc Co., Ltd. | 12 |
| Cereglide | Cerenovus, Inc. | 9 |
| Branchor X | Asahi Intecc Co., Ltd. | 9 |
| Stellar Guide Catheter | Balt USA, LLC | 8 |
| Esperance | Shanghai Wallaby Medical Technologies Co., Inc. | 6 |
| Fubuki XF | Asahi Intecc Co., Ltd. | 5 |
| Fubuki XF-R | Asahi Intecc Co., Ltd. | 4 |
| Apro 45 Intermediate Catheter | Alembic LLC | 4 |
| Apro 55 Intermediate Catheter | Alembic LLC | 4 |
| 87 NeuGlide Catheter | Piraeus Medical, Inc. | 4 |
| ACCESS25 Delivery Microcatheter | Penumbra Inc. | 4 |
| Midway | Penumbra Inc. | 4 |
Showing 12 of 54. All products under Catheter, Percutaneous, Neurovasculature
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243297 | 2025-01-14 |
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.