FDA.reportPublic FDA data

Peripheral Scoring Balloon Dilatation Catheter

Primary DI
06923533801101
Brand
Peripheral Scoring Balloon Dilatation Catheter
Company
DK Medical Technology Co., Ltd.
Model
DKL14-25120B
Published
2026-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K242254000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242254000D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.2025-04-21PNO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06923533801101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06923533801101069235338011016923533801101

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.

Regulatory Flags#

DUNS number
544100893
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06923533801064Peripheral Scoring Balloon Dilatation CatheterDKL14-2540B2026-06-24
06923533801071Peripheral Scoring Balloon Dilatation CatheterDKL14-2560B2026-06-24
06923533801088Peripheral Scoring Balloon Dilatation CatheterDKL14-2580B2026-06-24
06923533801095Peripheral Scoring Balloon Dilatation CatheterDKL14-25100B2026-06-24
06923533801118Peripheral Scoring Balloon Dilatation CatheterDKL14-25150B2026-06-24
06923533801125Peripheral Scoring Balloon Dilatation CatheterDKL14-2520C2026-06-24
06923533801132Peripheral Scoring Balloon Dilatation CatheterDKL14-2540C2026-06-24
06923533801149Peripheral Scoring Balloon Dilatation CatheterDKL14-2560C2026-06-24
06923533801156Peripheral Scoring Balloon Dilatation CatheterDKL14-2580C2026-06-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923533801064Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
06923533801071Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
06923533801088Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
06923533801095Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
06923533801118Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
06923533801125Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
06923533801132Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
06923533801149Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
06923533801156Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
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
06972253606367PTA 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