Catheter - India CDSCO Medical Device Registration

Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000245_5513d03dcf1e33d1e561f487a535dd4f_7b63fa84559106c17202c751132331d6. This device is marketed under the brand name Dualpro IVUS+NIRS Imaging Catheter. The license holder is NIPRO MEDICAL (INDIA) PRIVATE LIMITED, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Catheter

UID: IMP/MD/2023/000245_5513d03dcf1e33d1e561f487a535dd4f_7b63fa84559106c17202c751132331d6

Brand Name

Dualpro IVUS+NIRS Imaging Catheter

License Holder

NIPRO MEDICAL (INDIA) PRIVATE LIMITED

Device Class

Class D

Approving Authority

CDSCO

Product Information

a. The System is intended for the detection of lipid-corecontaining plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. c. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events. 2. The System is intended for ultrasound examination of coronary intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

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Catheter

Brand: Citrix-LA

Class B