R2P Metacross RX

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref BD-P30020ERModel 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: Kaneka PTA Balloon Dilatation Catheters EUDAMED
BD-P30020ER EUDAMEDFDA UDI
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-P30020ER FDA UDI
Primary DI / UDI-DI: 04540778166295 EUDAMEDFDA UDI
Basic UDI-DI: 4993478KNK0013Q EUDAMED
B-04540778166295 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 — FDA_510K, MDR, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — 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

United States Active

FDA_510K

European Union Active

CE/MDR

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K163479	Class IIa	Active
EUDAMED	European Union	CE/MDR	4993478KNK0013Q	Class IIa	Active
EUDAMED	European Union	CE/MDD	4993478KNK0013Q	Class IIa	Active

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Manufacturer

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

Sources (4)

EUDAMED 7598d9f7-45d2-4102-8dde-1e6424c4aaaf 61 fields · synced Jun 20, 2026
EUDAMED c8476194-dfa4-4835-9cac-2cdf850c262a 61 fields · synced May 16, 2026
FDA UDI d9c9dd57-16d9-489f-b94d-53b41cb4b3c5 38 fields · synced May 30, 2026
FDA 510(k) K163479 1 fields · synced May 18, 2026