Endoscope Retraction Tool for Intravascular Ultrasound - Vietnam Registration 240000476/PCBA-HCM
Access comprehensive regulatory information for Endoscope Retraction Tool for Intravascular Ultrasound in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại A medical device is registered under number 240000476/PCBA-HCM and manufactured by Boston Scientific Corporation. The authorized representative in Vietnam is CÔNG TY TNHH BOSTON SCIENTIFIC VIỆT NAM.
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Device Details
Registration Details
240000476/PCBA-HCM
000.00.19.H29-240311-0014
Permanent Sled
H749393160100
Technical Details
The pullback catheter combined with the IVUS system and the Motordrive control unit operates as a system and is indicated for patients undergoing interventional procedures in the coronary arteries, such as angioplasty and stent placement. The automatic pullback catheter is designed to be used when: • The user wants to standardize the method of acquiring and recording IVUS images; this may vary from case to case and from user to user; • The user wants to determine the linear distance, randomly, post-procedurally. This requires the lumen of the intravascular ultrasound catheter of the BSC to be pulled back at a known and uniform speed. The action is mechanized, thus much more uniform than manual manipulation; • The user wants to create 2D cross-sectional reconstructions along the length from a series of 2D ultrasound images. The images must be acquired at a uniform speed (consecutive frames) to be able to be reconstructed; • The use of the pullback catheter is intended to automatically reverse the lumen image CHI of the intravascular ultrasound catheter of the BSC compatible. The device is not intended to advance the catheter or the lumen image of the catheter by means of the motor and will not operate in this way.
Dates and Status
Mar 27, 2024

