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Pascal Precision

FDA UDI

Class III (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
PASCAL PRECISION FDA UDI
Generic Name
Heart valve clip FDA UDI
Device Name
PASCAL PRECISION SYSTEM - GUIDE SHEATH FDA UDI
Model / Reference
20000GSA FDA UDI
Description
PASCAL PRECISION SYSTEM - GUIDE SHEATH FDA UDI

Identifiers

Catalog Number
20000GSA FDA UDI
Primary DI / UDI-DI
00690103216967 FDA UDI
PMA Number
P220003 FDA UDI
FDA Product Code
NKM FDA UDI
GMDN Term
Heart valve clip 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Heart valve clip

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

Similar devices

Also classified as Heart valve clip.

Cleared under the same submission

P220003 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 41243957-0169-44c2-9392-85fbe906b3cc 37 fields · synced Jun 8, 2026