FDA.reportPublic FDA data

PTA Scoring Balloon Dilatation Catheter

Primary DI
06972253606367
Brand
PTA Scoring Balloon Dilatation Catheter
Company
DK Medical Technology Co., Ltd.
Model
DKT35-6020C
Published
2025-07-30
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
PNOCatheter, Percutaneous, Cutting/Scoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNOCatheter, Percutaneous, Cutting/ScoringCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232207000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232207000D·Kutting™ PTA Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.2024-03-07PNO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972253606367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972253606367069722536063676972253606367

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
06923533809596PTA High Pressure Balloon Dilatation CatheterHPA50-12020A72025-08-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923533801057Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-05-15
B090XC2201450XO ConstrainZIEN MEDICAL TECHNOLOGIES, INC.PNO2026-02-03
B090XC2201451XO ConstrainZIEN MEDICAL TECHNOLOGIES, INC.PNO2026-02-03
06972253606060PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606084PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606107PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606121PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606145PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606183PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606206PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606220PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606268PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606329PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606343PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606404PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606428PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606442PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606466PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606480PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253605780PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605797PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605803PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605810PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605827PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605834PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605841PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605858PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605865PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605872PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605889PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24