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Evoque

FDA UDI

Class III (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
EVOQUE FDA UDI
Generic Name
Tricuspid transcatheter heart valve bioprosthesis FDA UDI
Device Name
EDWARDS EVOQUE VALVE, 52MM FDA UDI
Model / Reference
9850EV52US FDA UDI
Description
EDWARDS EVOQUE VALVE, 52MM FDA UDI

Identifiers

Catalog Number
9850EV52US FDA UDI
Primary DI / UDI-DI
00690103217469 FDA UDI
PMA Number
P230013 FDA UDI
FDA Product Code
NPW FDA UDI
GMDN Term
Tricuspid transcatheter heart valve bioprosthesis FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 52 Millimeter FDA UDI

Category: Tricuspid transcatheter heart valve bioprosthesis

Evoque by Edwards Lifesciences LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tricuspid transcatheter heart valve bioprosthesis.

Cleared under the same submission

P230013 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edwards Lifesciences LLC

Sources (1)

  • FDA UDI e092272b-2df2-40f0-a2ba-6eb411e5f89e 38 fields · synced Jun 8, 2026