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SAPIEN 3 Ultra Delivery System

FDA UDI

Class III (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
SAPIEN 3 Ultra Delivery System FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
U.S. Edwards SAPIEN 3 Ultra Delivery System (26mm) FDA UDI
Model / Reference
9630TF23 FDA UDI
Description
U.S. Edwards SAPIEN 3 Ultra Delivery System (26mm) FDA UDI

Identifiers

Catalog Number
9630TF23A FDA UDI
Primary DI / UDI-DI
00690103201246 FDA UDI
PMA Number
P140031 FDA UDI
FDA Product Code
NPU FDA UDI
NPT FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable 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

No

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

Yes

FDA UDI

Serial Number

No

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 bioprosthesis

SAPIEN 3 Ultra Delivery System by Edwards Lifesciences LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mitral transcatheter heart valve bioprosthesis.

Cleared under the same submission

P140031 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 6e952784-3615-4dea-b8ea-a0eb6ec924e4 38 fields · synced Jun 8, 2026