FDA.reportPublic FDA data

PTA High Pressure Balloon Dilatation Catheter

Primary DI
06923533809367
Brand
PTA High Pressure Balloon Dilatation Catheter
Company
DK Medical Technology Co., Ltd.
Model
HPA75-9040B6
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
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
06923533809367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06923533809367069235338093676923533809367

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
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
06923533801101Peripheral Scoring Balloon Dilatation CatheterDKL14-25120B2026-06-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06934955914713Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914720Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914737Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914744Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914751Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914768Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914775Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914782Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914799Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914805Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914812Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914829Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914836Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914843Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914850Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914867Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914874Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914881Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914898Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914904Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914911Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914928Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
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