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Edwards Sapien 3 Transcatheter Heart Valve (thv)

FDA UDI

Class III (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) FDA UDI
Generic Name
Pulmonary transcatheter heart valve bioprosthesis FDA UDI
Device Name
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (29MM) FDA UDI
Model / Reference
9600TFX FDA UDI
Description
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (29MM) FDA UDI

Identifiers

Catalog Number
9600TFX29A FDA UDI
Primary DI / UDI-DI
00690103194364 FDA UDI
FDA Product Code
NPU FDA UDI
NPT FDA UDI
NPV FDA UDI
GMDN Term
Pulmonary 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

No

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

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Vascular catheter introduction set, nonimplantableAortic transcatheter heart valve bioprosthesis, stent-like frameworkMitral transcatheter heart valve bioprosthesisPulmonary transcatheter heart valve bioprosthesis

Edwards Sapien 3 Transcatheter Heart Valve (thv) by Edwards Lifesciences LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic crimper.

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 a8a9aa1f-f3a0-4ce2-84d3-79a94e5eedda 37 fields · synced Jun 6, 2026