PTA High Pressure Balloon Dilatation Catheter

FDA UDI

Class II (US FDA UDI)

by DK Medical Technology Co., Ltd.

Identity

Trade Name: PTA High Pressure Balloon Dilatation Catheter FDA UDI
Generic Name: Peripheral angioplasty balloon catheter, basic FDA UDI
Model / Reference: HPA130-12030C7 FDA UDI

Identifiers

Primary DI / UDI-DI: 06923533809640 FDA UDI
510(k) Number: K214009 FDA UDI
FDA Product Code: LIT FDA UDI
DQY FDA UDI
GMDN Term: Peripheral angioplasty balloon catheter, basic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Peripheral angioplasty balloon catheter, basic

PTA High Pressure Balloon Dilatation Catheter by DK Medical Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral angioplasty balloon catheter, basic.

Minerva PTA Balloon Dilatation Catheter — BrosMed Medical Co., Ltd. · Class IIa
Advocate™ — Merit Medical Systems, Inc. · Class II
Senri — KANEKA Corporation · Class IIa
Jade PTA Balloon Dilatation Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd. · Class II
ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
Pacific™ Plus — MEDTRONIC, INC. · Class II
Metacross OTW — KANEKA Corporation · Class IIa
Armada — Abbott Vascular · Class II

Cleared under the same submission

K214009 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: DK Medical Technology Co., Ltd.

Sources (1)

FDA UDI e9f195e1-d6aa-415c-86d1-b41ae4022e9c 33 fields · synced May 30, 2026