Toro 88 Superbore Catheter
Toro 88 Superbore Catheter introduces interventional devices into peripheral, coronary or neurovascular vessels. It is a variable-stiffness, single-lumen catheter with a Luer lock hub. A…
Toro 88 Superbore Catheter introduces interventional devices into peripheral, coronary or neurovascular vessels. It is a variable-stiffness, single-lumen catheter with a Luer lock hub. A lubricious inner liner helps the catheter advance over a steerable guidewire or microcatheter.
The shaft combines stainless-steel and nitinol wires with polymers of differing hardness. A hydrophilic coating covers the distal exterior to reduce friction during manipulation. A single radiopaque marker at the soft distal tip provides a fluoroscopic positioning reference.
Listed Item
The Toro 88 Superbore Catheter is a sterile, single-use catheter designed to facilitate the introduction of interventional devices into the vasculature. It is indicated for use in the peripheral, coronary, and neuro vasculature.
Supply and Accessory
The catheter is supplied sterile for single use, with a split introducer sheath as its accessory. Its straight distal edge differs from the beveled edge of the comparison catheters. The catheter is a delivery pathway for other interventional devices rather than the therapeutic device itself.
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 | Toro Neurovascular, Inc., United States |
|---|---|
| FDA product code | QJP |
| Device type | Catheter, Percutaneous, Neurovasculature |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K252297 |
| Record published | 2026-02-02 |
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 |
| Storage | Special storage condition: Keep dry; Special storage condition: Keep away from sunlight; Special storage condition: Store at room temperature |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AX088118 | Catheter Inner Diameter | In distribution |
| AX088110 | Catheter Inner Diameter | 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 |
|---|---|
| K252297 | 2026-01-16 |
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.