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 06923533801330 Peripheral Scoring Balloon Dilatation Catheter DKL14-3020C 2026-07-30 06923533801347 Peripheral Scoring Balloon Dilatation Catheter DKL14-3040C 2026-07-30 06923533801354 Peripheral Scoring Balloon Dilatation Catheter DKL14-3060C 2026-07-30 06923533801361 Peripheral Scoring Balloon Dilatation Catheter DKL14-3080C 2026-07-30 06923533801378 Peripheral Scoring Balloon Dilatation Catheter DKL14-30100C 2026-07-30 06923533801385 Peripheral Scoring Balloon Dilatation Catheter DKL14-30120C 2026-07-30 06923533801392 Peripheral Scoring Balloon Dilatation Catheter DKL14-30150C 2026-07-30 06923533801408 Peripheral Scoring Balloon Dilatation Catheter DKL14-3020D 2026-07-30 06923533801415 Peripheral Scoring Balloon Dilatation Catheter DKL14-3040D 2026-07-30 06923533801422 Peripheral Scoring Balloon Dilatation Catheter DKL14-3060D 2026-07-30 06923533801439 Peripheral Scoring Balloon Dilatation Catheter DKL14-3080D 2026-07-30 06923533801446 Peripheral Scoring Balloon Dilatation Catheter DKL14-30100D 2026-07-30 06923533801453 Peripheral Scoring Balloon Dilatation Catheter DKL14-30120D 2026-07-30 06923533801460 Peripheral Scoring Balloon Dilatation Catheter DKL14-30150D 2026-07-30 06923533801477 Peripheral Scoring Balloon Dilatation Catheter DKL14-3520B 2026-07-30 06923533801484 Peripheral Scoring Balloon Dilatation Catheter DKL14-3540B 2026-07-30 06923533801491 Peripheral Scoring Balloon Dilatation Catheter DKL14-3560B 2026-07-30 06923533801507 Peripheral Scoring Balloon Dilatation Catheter DKL14-3580B 2026-07-30 06923533801514 Peripheral Scoring Balloon Dilatation Catheter DKL14-35100B 2026-07-30 06923533801521 Peripheral Scoring Balloon Dilatation Catheter DKL14-35120B 2026-07-30
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