FDA.reportPublic FDA data

Peripheral Scoring Balloon Dilatation Catheter

Primary DI
06923533802566
Brand
Peripheral Scoring Balloon Dilatation Catheter
Company
DK Medical Technology Co., Ltd.
Model
DKL18-60100B
Published
2026-10-28
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
06923533802566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06923533802566069235338025666923533802566

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
06923533802405Peripheral Scoring Balloon Dilatation CatheterDKL18-5560C2026-10-28
06923533802429Peripheral Scoring Balloon Dilatation CatheterDKL18-55100C2026-10-28
06923533802436Peripheral Scoring Balloon Dilatation CatheterDKL18-55120C2026-10-28
06923533802443Peripheral Scoring Balloon Dilatation CatheterDKL18-55150C2026-10-28
06923533802450Peripheral Scoring Balloon Dilatation CatheterDKL18-5520D2026-10-28
06923533802467Peripheral Scoring Balloon Dilatation CatheterDKL18-5540D2026-10-28
06923533802474Peripheral Scoring Balloon Dilatation CatheterDKL18-5560D2026-10-28
06923533802481Peripheral Scoring Balloon Dilatation CatheterDKL18-5580D2026-10-28
06923533802498Peripheral Scoring Balloon Dilatation CatheterDKL18-55100D2026-10-28
06923533802504Peripheral Scoring Balloon Dilatation CatheterDKL18-55120D2026-10-28
06923533802511Peripheral Scoring Balloon Dilatation CatheterDKL18-55150D2026-10-28
06923533802528Peripheral Scoring Balloon Dilatation CatheterDKL18-6020B2026-10-28
06923533802535Peripheral Scoring Balloon Dilatation CatheterDKL18-6040B2026-10-28
06923533802542Peripheral Scoring Balloon Dilatation CatheterDKL18-6060B2026-10-28
06923533802559Peripheral Scoring Balloon Dilatation CatheterDKL18-6080B2026-10-28
06923533802573Peripheral Scoring Balloon Dilatation CatheterDKL18-60120B2026-10-28
06923533802580Peripheral Scoring Balloon Dilatation CatheterDKL18-60150B2026-10-28
06923533802597Peripheral Scoring Balloon Dilatation CatheterDKL18-6020C2026-10-28
06923533802603Peripheral Scoring Balloon Dilatation CatheterDKL18-6040C2026-10-28
06923533802610Peripheral Scoring Balloon Dilatation CatheterDKL18-6060C2026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923533802405Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802429Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802436Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802443Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802450Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802467Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802474Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802481Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802498Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802504Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802511Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802528Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802535Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802542Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802559Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802573Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802580Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802597Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802603Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802610Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802627Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802634Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802641Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802658Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802665Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802672Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802689Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802696Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802702Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28
06923533802719Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-28