Jade PTA Balloon Dilatation Catheter

FDA UDI

Class II (US FDA UDI)

by OrbusNeich Medical (ShenZhen) Co., Ltd.

Identity

Trade Name: Jade PTA Balloon Dilatation Catheter FDA UDI
Generic Name: Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name: Percutaneous Transluminal Angioplasty (PTA) Catheter FDA UDI
Model / Reference: 581518012 FDA UDI
Description: Percutaneous Transluminal Angioplasty (PTA) Catheter FDA UDI

Identifiers

Primary DI / UDI-DI: 06934955900051 FDA UDI
510(k) Number: K201794 FDA UDI
FDA Product Code: LIT 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

Jade PTA Balloon Dilatation Catheter by OrbusNeich Medical (ShenZhen) 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
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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
RapidCross — Covidien LP · Class II

Cleared under the same submission

K201794 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

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Manufacturer

Manufacturer: OrbusNeich Medical (ShenZhen) Co., Ltd.

Sources (1)

FDA UDI c6cbe84e-d6a1-4d34-b41b-eadc66662dcb 34 fields · synced May 30, 2026