pORTAL® Steerable Hydrophilic Guidewire
The pORTAL Guidewire is a disposable medical device designed for single use only. It is designed to selectively introduce and position catheters and other interventional devices within…
The pORTAL Guidewire is a disposable medical device designed for single use only. It is designed to selectively introduce and position catheters and other interventional devices within target vessels. In order to achieve this purpose, the guidewire must be capable of being steered through blood vessels. This necessitates pushing and torqueing capability within the product. The design of the distal section of the guidewire provides steerability, while maintaining the flexibility necessary to negotiate the tortuous path of the blood vessel network. Coatings are placed on the device to improve the lubricity and ease in its advancement through the guide catheter and the blood vessels. Two accessories are provided within the package. These are a Torquer device and an introducer Needle. Both can be used to aid the successful use of the device.
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Terumo Medical Products (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Shanghai Achieva Medical Suzhou Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Deepintec Scientific Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Enlight Medical Technologies (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Phenox Limited, Ireland |
|---|---|
| FDA product code | MOF |
| Device type | Guide, Wire, Catheter, Neurovasculature |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K191687 |
| Record published | 2020-02-06 |
| Record revised | 2021-12-22 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PORT-14-200-1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Willow 14 Guidewire | Arbor Endovascular | 22 |
| Cypress 14 Guidewire | Arbor Endovascular | 9 |
| Aristotle | Scientia Vascular | 8 |
| DCwire™ | Shanghai Achieva Medical Suzhou Co., Ltd. | 8 |
| Synchro Select | Stryker GmbH | 6 |
| Chikai Nexus 014 | Asahi Intecc Co., Ltd. | 6 |
| Hybrid Guidewire | Balt USA, LLC | 5 |
| Chikai | Asahi Intecc Co., Ltd. | 4 |
| Volo | Scientia Vascular | 4 |
| Chikai black | Asahi Intecc Co., Ltd. | 4 |
| Chikai Nexus petit | Asahi Intecc Co., Ltd. | 3 |
| Agility | Cerenovus, Inc. | 3 |
Showing 12 of 42. All products under Guide, Wire, Catheter, Neurovasculature
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.