R2P Metacross RX

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref BD-P70100ERModel Kaneka PTA Balloon Dilatation Catheters

by KANEKA Corporation

Identity

Trade Name: R2P Metacross RX EUDAMEDFDA UDI
Generic Name: Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name: R2P Metacross RX EUDAMED
R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm). FDA UDI
Model / Reference: BD-P70100ER EUDAMEDFDA UDI
Kaneka PTA Balloon Dilatation Catheters EUDAMED
Description: R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm). FDA UDI

Identifiers

Catalog Number: BD-P70100ER FDA UDI
Primary DI / UDI-DI: 04540778166851 EUDAMEDFDA UDI
Basic UDI-DI: B-04540778166851 EUDAMED
4993478KNK0013Q EUDAMED
510(k) Number: K163479 FDA UDI
FDA Product Code: LIT FDA UDI
EMDN Code: C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
GMDN Term: Peripheral angioplasty balloon catheter, basic FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Peripheral angioplasty balloon catheter, basic

R2P Metacross RX by KANEKA Corporation — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, 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
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
Armada — Abbott Vascular · Class II
RapidCross — Covidien LP · Class II
Chocolate PTA Balloon Catheter — TRIREME MEDICAL, LLC · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	B-04540778166851	Class IIa	Active
EUDAMED	European Union	CE/MDD	B-04540778166851	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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

Manufacturer

Manufacturer: KANEKA Corporation
EUDAMED SRN: JP-MF-000022143
Authorised Representative: Kaneka Medical Europe N.V. BE-AR-000010091

Sources (3)

EUDAMED 7b8ff933-6ddd-4aaa-ad5e-8cfd9a6faf07 61 fields · synced Jul 8, 2026
EUDAMED c01fb1f0-e08b-4950-91a8-b07d3cf30ad2 61 fields · synced May 18, 2026
FDA UDI 4e257bf2-c4ae-40ba-86a4-cd419876e1ad 38 fields · synced May 30, 2026