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Perceval S

FDA UDI

Class III (US FDA UDI)

by Corcym Srl

Identity

Trade Name
PERCEVAL S FDA UDI
Generic Name
Self-expandable heart valve prosthesis post-dilation balloon catheter FDA UDI
Model / Reference
ICV1149 FDA UDI

Identifiers

Primary DI / UDI-DI
08022057014252 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.

Cleared under the same submission

P150011 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Corcym Srl

Sources (1)

  • FDA UDI 55bb1fa2-df89-4a04-8e04-af98c16c6b73 33 fields · synced May 30, 2026