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Verrata Plus Pressure Guide Wire

EUDAMEDFDA UDIFDA 510(k)

Class III (EU MDR)

Ref 10185JP510(k) K210235

by Volcano Corporation

Identity

Trade Name
Verrata Plus Pressure Guide Wire EUDAMEDFDA UDI
Generic Name
Catheter-tip transducer, pressure FDA UDI
Device Name
Verrata Plus EUDAMED
Model / Reference
10185JP EUDAMEDFDA UDI

Identifiers

Catalog Number
10185JP FDA UDI
Primary DI / UDI-DI
00845225002886 EUDAMEDFDA UDI
Basic UDI-DI
B-00845225002886 EUDAMED
510(k) Number
K161887 FDA UDI
K210235 FDA UDI
FDA Product Code
DXO FDA UDI
DQX FDA UDI
EMDN Code
C04030101 DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC EUDAMED
GMDN Term
Catheter-tip transducer, pressure FDA UDI

Classification

Device Class
Class III EUDAMED
Class II FDA UDI
Regulation Number
870.2870 FDA UDI
870.1330 FDA UDI
Market of Registration
Belgium EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 0.014 Inch FDA UDI
Length — 185 Centimeter FDA UDI

Verrata Plus Pressure Guide Wire by Volcano Corporation — Class III — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Volcano Corporation
EUDAMED SRN
US-MF-000020094
Authorised Representative
Volcano Europe BE-AR-000000929

Sources (3)

  • EUDAMED 076873d0-7dbc-413c-88bb-b7da6f9a45d1 85 fields · synced Jun 19, 2026
  • FDA UDI d5083926-f1aa-449b-aff1-ab02f5b60e1d 37 fields · synced May 29, 2026
  • FDA 510(k) K210235 1 fields · synced May 18, 2026