ACCESS25 Delivery Microcatheter
Access25 Delivery Microcatheter provides a pathway for delivering contrast agents or therapeutic devices such as occlusion coils into peripheral or neurovascular vessels. It is used with a…
Access25 Delivery Microcatheter provides a pathway for delivering contrast agents or therapeutic devices such as occlusion coils into peripheral or neurovascular vessels. It is used with a guide catheter and microguidewire to reach distal anatomy.
The single-lumen catheter has a hydrophilic coating and is available with straight or shaped distal tips. Supplied stainless steel mandrels allow the physician to shape the tip for the intended route.
Listed Item
ACCESS25 150Micro, Straight
Dimensions and Supply
The catheter has a minimum inner diameter of 0.025 inches and is available in 150, 160 and 170 cm effective lengths. Tip options include 45-degree, 90-degree and J-shaped configurations. It is supplied sterile after ethylene oxide processing 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 | 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) | K242033 |
| Record published | 2024-12-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PXAC045-A | In distribution | |
| PXAC130-A | In distribution | |
| PXAC090-A | In distribution | |
| PXACSTR-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 |
| Midway | 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.