Identity
- Trade Name
- PASCAL FDA UDI
- Generic Name
- Cardiac implantation catheter platform, single-use FDA UDI
- Device Name
- PASCAL TABLE US COMMERCIAL FDA UDI
- Model / Reference
- 10000T FDA UDI
- Description
- PASCAL TABLE US COMMERCIAL FDA UDI
Identifiers
- Catalog Number
- 10000TA FDA UDI
- Primary DI / UDI-DI
- 00690103216981 FDA UDI
- PMA Number
- P220003 FDA UDI
- FDA Product Code
- NKM FDA UDI
- GMDN Term
- Cardiac implantation catheter platform, single-use FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Category: Cardiac implantation catheter platform, single-use
Pascal by Edwards Lifesciences LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P220003 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI d5e382c8-8812-46b1-9343-4268a8d8336e 37 fields · synced Jun 8, 2026