Identity
- Trade Name
- PERCEVAL S FDA UDI
- Generic Name
- Self-expandable heart valve prosthesis post-dilation balloon catheter FDA UDI
- Model / Reference
- ICV1216 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08022057014771 FDA UDI
- PMA Number
- P150011 FDA UDI
- FDA Product Code
- LWR FDA UDI
- GMDN Term
- Self-expandable heart valve prosthesis post-dilation balloon catheter 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
Category: Self-expandable heart valve prosthesis post-dilation balloon catheter
Perceval S by Corcym Srl — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Self-expandable heart valve prosthesis post-dilation balloon catheter.
- PERCEVAL S — Corcym Inc. · Class III
- PERCEVAL S — Corcym Inc. · Class III
- PERCEVAL S — Corcym Inc. · Class III
- Perceval S Single Use MICS Accessory Kit — CORCYM SRL
- PERCEVAL S — CORCYM SRL · Class III
- PERCEVAL S — CORCYM SRL · Class III
- Perceval S Single Use MICS Accessory Kit — CORCYM SRL
- PERCEVAL S — CORCYM SRL · Class III
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Corcym Srl
Sources (1)
- FDA UDI 1b9b54e7-91ab-4fa9-8c00-cfb672e17e90 33 fields · synced May 30, 2026