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510(k) Data Aggregation
K Number
K233205Device Name
Distal Access Catheter
Manufacturer
Date Cleared
2023-12-22
(85 days)
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Shanghai HeartCare Medical Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The Distal Access Catheter is also indicated for use as a conduit for retrieval devices.
Device Description
The Distal Access Catheter is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The catheter comes in Straight (with no shaping of the catheter tip) and Curved (curved catheter tip) models based on the distal end. The catheter shaft has a hydrophilic coating on the distal end of the shaft to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end.
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