Perceval Plus

FDA UDI

Class III (US FDA UDI)

by Corcym Srl

Identity

Trade Name: PERCEVAL PLUS FDA UDI
Generic Name: Aortic open-surgery heart valve bioprosthesis FDA UDI
Device Name: SUTURELESS AORTIC HEART VALVE FDA UDI
Model / Reference: PVF-M FDA UDI
Description: SUTURELESS AORTIC HEART VALVE FDA UDI

Identifiers

Catalog Number: PVF-M FDA UDI
Primary DI / UDI-DI: 08022057015372 FDA UDI
PMA Number: P150011 FDA UDI
FDA Product Code: LWR FDA UDI
GMDN Term: Aortic open-surgery heart valve bioprosthesis 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Aortic open-surgery heart valve bioprosthesis

Perceval Plus by Corcym Srl — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Aortic open-surgery heart valve bioprosthesis.

MOSAIC ULTRA® — MEDTRONIC, INC. · Class III
MOSAIC ULTRA® — MEDTRONIC, INC. · Class III
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC · Class III
Trifecta™ — ST. JUDE MEDICAL, INC. · Class III
CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC · Class III
INSPIRIS RESILIA AORTIC VALVE — Edwards Lifesciences LLC · Class III
MOSAIC® — MEDTRONIC, INC. · Class III
CARPENTIER-EDWARDS S.A.VBIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC · Class III

Cleared under the same submission

P150011 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: Corcym Srl

Sources (1)

FDA UDI 265d8d4b-a26c-42a7-95a9-f98131377b96 35 fields · synced May 30, 2026