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Steerable Hydrophilic Guidewire - India CDSCO Medical Device Registration

Steerable Hydrophilic Guidewire is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000710_f0254be58e964e5bd765663d80aa5774_08e6fea82e52273f3a0a4b5ec89817e3. This device is marketed under the brand name pITA. The license holder is Pack Deal, and it is classified as Device Class Class D. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class D
Steerable Hydrophilic Guidewire
UID: IMP/MD/2023/000710_f0254be58e964e5bd765663d80aa5774_08e6fea82e52273f3a0a4b5ec89817e3

Brand Name

pITA

License Holder

Pack Deal

Device Class

Class D

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 (pITA). 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

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