PTA High Pressure Balloon Dilatation Catheter

GUDID 06923533808704

DK Medical Technology Co., Ltd.

Peripheral angioplasty balloon catheter, basic
Primary Device ID06923533808704
NIH Device Record Key37f166e5-83ab-4b54-9cb7-03fee3bd9d98
Commercial Distribution StatusIn Commercial Distribution
Brand NamePTA High Pressure Balloon Dilatation Catheter
Version Model NumberHPA75-6080B5
Company DUNS544100893
Company NameDK Medical Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106923533808704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LITCatheter, Angioplasty, Peripheral, Transluminal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-24
Device Publish Date2025-07-16

On-Brand Devices [PTA High Pressure Balloon Dilatation Catheter]

06923533809695HPA75-12060B7
06923533809510HPA75-10040B6
06923533808889HPA75-7040B5
06923533808643HPA75-6040B5
06923533808636HPA50-6040A5
06923533808391HPA50-5040A5
06923533808155HPA50-4040A5
06923533808162HPA75-4040B5
06923533809725HPA75-12080B7
06923533809664HPA75-12040B7
06923533809572HPA75-10080B6
06923533809428HPA75-9080B6
06923533809367HPA75-9040B6
06923533809213HPA75-80100B6
06923533809183HPA75-8080B6
06923533809121HPA75-8040B6
06923533808971HPA75-70100B5
06923533808940HPA75-7080B5
06923533808735HPA75-60100B5
06923533808704HPA75-6080B5
06923533808490HPA75-50100B5
06923533808469HPA75-5080B5
06923533808407HPA75-5040B5
06923533808223HPA75-4080B5

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