Home GUDID 06923533808407 PTA High Pressure Balloon Dilatation Catheter
Primary DI 06923533808407
Brand PTA High Pressure Balloon Dilatation Catheter
Company DK Medical Technology Co., Ltd.
Model HPA75-5040B5
Published 2025-07-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name LIT Catheter, Angioplasty, Peripheral, Transluminal QTY Von Willebrand Factor Assay
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular 2 QTY Von Willebrand Factor Assay Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 06923533808407 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06923533808407 06923533808407 6923533808407
GMDN Terms# Term, Definition table Term Definition Peripheral angioplasty balloon catheter, basic A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
Regulatory Flags# DUNS number 544100893 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 06923533801057 Peripheral Scoring Balloon Dilatation Catheter DKL14-2520B 2026-05-15 06923533808728 PTA High Pressure Balloon Dilatation Catheter HPA50-60100A5 2025-08-28 06923533809527 PTA High Pressure Balloon Dilatation Catheter HPA130-10040C6 2025-08-13 06923533809534 PTA High Pressure Balloon Dilatation Catheter HPA50-10060A6 2025-08-13 06923533809541 PTA High Pressure Balloon Dilatation Catheter HPA75-10060B6 2025-08-13 06923533809558 PTA High Pressure Balloon Dilatation Catheter HPA130-10060C6 2025-08-13 06923533809589 PTA High Pressure Balloon Dilatation Catheter HPA130-10080C6 2025-08-13 06923533809596 PTA High Pressure Balloon Dilatation Catheter HPA50-12020A7 2025-08-13 06923533809602 PTA High Pressure Balloon Dilatation Catheter HPA75-12020B7 2025-08-13 06923533809619 PTA High Pressure Balloon Dilatation Catheter HPA130-12020C7 2025-08-13 06923533809626 PTA High Pressure Balloon Dilatation Catheter HPA50-12030A7 2025-08-13 06923533809633 PTA High Pressure Balloon Dilatation Catheter HPA75-12030B7 2025-08-13 06923533809640 PTA High Pressure Balloon Dilatation Catheter HPA130-12030C7 2025-08-13 06923533809657 PTA High Pressure Balloon Dilatation Catheter HPA50-12040A7 2025-08-13 06923533809671 PTA High Pressure Balloon Dilatation Catheter HPA130-12040C7 2025-08-13 06923533809688 PTA High Pressure Balloon Dilatation Catheter HPA50-12060A7 2025-08-13 06923533809701 PTA High Pressure Balloon Dilatation Catheter HPA130-12060C7 2025-08-13 06923533809718 PTA High Pressure Balloon Dilatation Catheter HPA50-12080A7 2025-08-13 06923533809732 PTA High Pressure Balloon Dilatation Catheter HPA130-12080C7 2025-08-13 06923533809282 PTA High Pressure Balloon Dilatation Catheter HPA130-80150C6 2025-08-12
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