JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

FDA UDI

Class II (US FDA UDI)

by OrbusNeich Medical (ShenZhen) Co., Ltd.

Identity

Trade Name: JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW FDA UDI
Generic Name: Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name: Percutaneous Transluminal Angioplasty Balloon Catheter FDA UDI
Model / Reference: 5855-040-12 FDA UDI
Description: Percutaneous Transluminal Angioplasty Balloon Catheter FDA UDI

Identifiers

Catalog Number: 5855-040-12 FDA UDI
Primary DI / UDI-DI: 06934955930515 FDA UDI
510(k) Number: K241025 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 PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW by OrbusNeich Medical (ShenZhen) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID

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
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

K241025 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 6798cf58-b0f3-4da1-8770-4a4f5f671b1b 36 fields · synced May 30, 2026