Steerable Hydrophilic Guidewire
- UID
- IMP/MD/2023/000120_dedb70e8e5ba52df5c6c7a58428c7211_281443a5919cedd92b09a70007861c13
- Device class
- Class D
- Brand name
- p48 MW
- License holder
- Sunrise Imaging Systems
- Approving authority
- CDSCO
- Product information
- The intended use of pORTAL is to facilitate the selective introduction and positioning of catheters and other interventional devices in extra- and intracranial brain-supplying arteries and in extra- and intracranial brain-draining veins. The intervention using pORTAL is usually done through femoral artery access using a sheath and a guide catheter. For transvenous access a sheath is introduced in a suitable venous vessel (p48 MW). The duration of use is transient, thus, the device is under normal circumstances intended for continuous use for less than 60 minutes. Indications: pORTAL, consisting of pORTAL Steerable Hydrophilic Guidewire and optional pORTAL EXT Extension Wire, is intended for use in extra- and intracranial brain-supplying arteries and in extra- and intracranial brain-draining veins. It can be used to facilitate the selective introduction and positioning of catheters and other interventional devices within target vessels
Steerable Hydrophilic Guidewire is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000120_dedb70e8e5ba52df5c6c7a58428c7211_281443a5919cedd92b09a70007861c13. This device is marketed under the brand name p48 MW. The license holder is Sunrise Imaging Systems, and it is classified as Device Class Class D. The approving authority is CDSCO.
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