FDA.reportPublic FDA data

PTA High Pressure Balloon Dilatation Catheter

Primary DI
06923533809596
Brand
PTA High Pressure Balloon Dilatation Catheter
Company
DK Medical Technology Co., Ltd.
Model
HPA50-12020A7
Published
2025-08-13
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
CodeName
DQYCatheter, Percutaneous
LITCatheter, Angioplasty, Peripheral, Transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K214009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K214009000D·Kaptain PTA High Pressure Balloon Dilatation CatheterDk Medical Technology Co., Ltd.2023-04-05LIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06923533809596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06923533809596069235338095966923533809596

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA 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.

Sterilization Methods#

Method table
Method

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 DIBrandModelCatalogPublished
06923533801057Peripheral Scoring Balloon Dilatation CatheterDKL14-2520B2026-05-15
06923533808728PTA High Pressure Balloon Dilatation CatheterHPA50-60100A52025-08-28
06923533809527PTA High Pressure Balloon Dilatation CatheterHPA130-10040C62025-08-13
06923533809534PTA High Pressure Balloon Dilatation CatheterHPA50-10060A62025-08-13
06923533809541PTA High Pressure Balloon Dilatation CatheterHPA75-10060B62025-08-13
06923533809558PTA High Pressure Balloon Dilatation CatheterHPA130-10060C62025-08-13
06923533809589PTA High Pressure Balloon Dilatation CatheterHPA130-10080C62025-08-13
06923533809602PTA High Pressure Balloon Dilatation CatheterHPA75-12020B72025-08-13
06923533809619PTA High Pressure Balloon Dilatation CatheterHPA130-12020C72025-08-13
06923533809626PTA High Pressure Balloon Dilatation CatheterHPA50-12030A72025-08-13
06923533809633PTA High Pressure Balloon Dilatation CatheterHPA75-12030B72025-08-13
06923533809640PTA High Pressure Balloon Dilatation CatheterHPA130-12030C72025-08-13
06923533809657PTA High Pressure Balloon Dilatation CatheterHPA50-12040A72025-08-13
06923533809671PTA High Pressure Balloon Dilatation CatheterHPA130-12040C72025-08-13
06923533809688PTA High Pressure Balloon Dilatation CatheterHPA50-12060A72025-08-13
06923533809701PTA High Pressure Balloon Dilatation CatheterHPA130-12060C72025-08-13
06923533809718PTA High Pressure Balloon Dilatation CatheterHPA50-12080A72025-08-13
06923533809732PTA High Pressure Balloon Dilatation CatheterHPA130-12080C72025-08-13
06923533809282PTA High Pressure Balloon Dilatation CatheterHPA130-80150C62025-08-12
06923533809299PTA High Pressure Balloon Dilatation CatheterHPA50-9020A62025-08-12

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