Midway
The FDA filing names MIDWAY Delivery Catheter and its MIDWAY 43 and MIDWAY 62 variants. It describes them as single-lumen percutaneous catheters that provide a conduit for introducing…
The FDA filing names MIDWAY Delivery Catheter and its MIDWAY 43 and MIDWAY 62 variants. It describes them as single-lumen percutaneous catheters that provide a conduit for introducing interventional devices.
The stated indication is introduction of interventional devices into the peripheral, coronary and neuro vasculature. The subject device includes both named catheter variants.
Listed Item
MIDWAY 43 Delivery Catheter, 115cm, no CE
Catheter Features
The catheter has coil reinforcement and variable stiffness, with a radiopaque marker band at the distal end and a Luer hub at the proximal end. Its distal shaft segment has a hydrophilic coating.
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 | Penumbra Inc., United States |
|---|---|
| FDA product code | QJP |
| Device type | Catheter, Percutaneous, Neurovasculature |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K233201 |
| Record published | 2024-04-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 43MWAY115-A | In distribution | |
| 62MWAY115-A | In distribution | |
| 62MWAY125-A | In distribution | |
| 43MWAY125-A | 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 |
| Marblehead Medical | Marblehead Medical, LLC | 4 |
Showing 12 of 54. All products under Catheter, Percutaneous, Neurovasculature
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242033 | 2024-12-11 |
| K233201 | 2024-03-27 |
| K221822 | 2022-11-04 |
| K213390 | 2022-08-18 |
| K212838 | 2022-05-27 |
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.