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CDSCO UID IMP/MD/2020/000435_f19bf33bb9d42f97d43c537759591c5a_65a807ebd299e223d05106b3f02ea7a0

PTA – Sirolimus Eluting Catheter

Heartwave Medical Private Limited ,C-67, THIRD FLOOR, DDA SHEDS, OKHLA INDUSTRIAL AREA PHASE-I ,New Delhi Delhi ,110020 ,India·Device Class Class C·India CDSCO·Brand: ALEX PTA
Registration details
UID
IMP/MD/2020/000435_f19bf33bb9d42f97d43c537759591c5a_65a807ebd299e223d05106b3f02ea7a0
Device class
Class C
Brand name
ALEX PTA
License holder
Heartwave Medical Private Limited ,C-67, THIRD FLOOR, DDA SHEDS, OKHLA INDUSTRIAL AREA PHASE-I ,New Delhi Delhi ,110020 ,India
Approving authority
CDSCO
Product information
Intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistula. This catheter is not intended for the expansion or delivery of stents
Similar products (1)
Other products with the same name or brand
PTCA – Sirolimus Eluting Catheter
Brand: ALEX PTA
Heartwave Medical Private Limited ,C-67, THIRD FLOOR, DDA SHEDS, OKHLA INDUSTRIAL AREA PHASE-I ,New Delhi Delhi ,110020 ,India
Class C
Other products from Heartwave Medical Private Limited ,C-67, THIRD FLOOR, DDA SHEDS, OKHLA INDUSTRIAL AREA PHASE-I ,New Delhi Delhi ,110020 ,India
Products from the same license holder (2 products)
L605 Sirolimus Eluting Stent
Brand: Cobalt Chromium
Class D
PTCA – Sirolimus Eluting Catheter
Brand: ALEX PTA
Class C
About this record

PTA – Sirolimus Eluting Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000435_f19bf33bb9d42f97d43c537759591c5a_65a807ebd299e223d05106b3f02ea7a0. This device is marketed under the brand name ALEX PTA. The license holder is Heartwave Medical Private Limited ,C-67, THIRD FLOOR, DDA SHEDS, OKHLA INDUSTRIAL AREA PHASE-I ,New Delhi Delhi ,110020 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.

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