FDA.reportPublic FDA data

PTA High Pressure Balloon Dilatation Catheter

Primary DI
06923533808407
Brand
PTA High Pressure Balloon Dilatation Catheter
Company
DK Medical Technology Co., Ltd.
Model
HPA75-5040B5
Published
2025-07-16
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
LITCatheter, Angioplasty, Peripheral, Transluminal
QTYVon Willebrand Factor Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2
QTYVon Willebrand Factor AssayHematology2

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
06923533808407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06923533808407069235338084076923533808407

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
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
06923533802566Peripheral Scoring Balloon Dilatation CatheterDKL18-60100B2026-10-28
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

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