FDA.reportPublic FDA data

PTA High Pressure Balloon Dilatation Catheter

Primary DI
06923533809688
Brand
PTA High Pressure Balloon Dilatation Catheter
Company
DK Medical Technology Co., Ltd.
Model
HPA50-12060A7
Published
2025-08-13
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
06923533809688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06923533809688069235338096886923533809688

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
06923533801330Peripheral Scoring Balloon Dilatation CatheterDKL14-3020C2026-07-30
06923533801347Peripheral Scoring Balloon Dilatation CatheterDKL14-3040C2026-07-30
06923533801354Peripheral Scoring Balloon Dilatation CatheterDKL14-3060C2026-07-30
06923533801361Peripheral Scoring Balloon Dilatation CatheterDKL14-3080C2026-07-30
06923533801378Peripheral Scoring Balloon Dilatation CatheterDKL14-30100C2026-07-30
06923533801385Peripheral Scoring Balloon Dilatation CatheterDKL14-30120C2026-07-30
06923533801392Peripheral Scoring Balloon Dilatation CatheterDKL14-30150C2026-07-30
06923533801408Peripheral Scoring Balloon Dilatation CatheterDKL14-3020D2026-07-30
06923533801415Peripheral Scoring Balloon Dilatation CatheterDKL14-3040D2026-07-30
06923533801422Peripheral Scoring Balloon Dilatation CatheterDKL14-3060D2026-07-30
06923533801439Peripheral Scoring Balloon Dilatation CatheterDKL14-3080D2026-07-30
06923533801446Peripheral Scoring Balloon Dilatation CatheterDKL14-30100D2026-07-30
06923533801453Peripheral Scoring Balloon Dilatation CatheterDKL14-30120D2026-07-30
06923533801460Peripheral Scoring Balloon Dilatation CatheterDKL14-30150D2026-07-30
06923533801477Peripheral Scoring Balloon Dilatation CatheterDKL14-3520B2026-07-30
06923533801484Peripheral Scoring Balloon Dilatation CatheterDKL14-3540B2026-07-30
06923533801491Peripheral Scoring Balloon Dilatation CatheterDKL14-3560B2026-07-30
06923533801507Peripheral Scoring Balloon Dilatation CatheterDKL14-3580B2026-07-30
06923533801514Peripheral Scoring Balloon Dilatation CatheterDKL14-35100B2026-07-30
06923533801521Peripheral Scoring Balloon Dilatation CatheterDKL14-35120B2026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00802526625008ACUITY™BOSTON SCIENTIFIC CORPORATIONDQY2026-10-15
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008400ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008431ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008448ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00857545008158ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008165ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008172ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008189ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008196ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008202ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008219ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008226ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008233ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008240ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008257ZebraQ'APEL MEDICAL LLCDQY2025-01-03