PERCEVAL S

Basic Information

• Brand Name: PERCEVAL S
• Primary DI: 08022057014825
• Version / Model: ICV1234
• Company Name: CORCYM SRL
• Labeler DUNS: 441454802
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-06
• Public Version: 5
• Public Version Date: 2023-02-08
• Public Version Status: Update
• Public Device Record Key: 5ab1e4df-b77f-4e8f-9fcc-bf1a45e0482e

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LWR	heart-valve, non-allograft tissue	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
58707	Self-expandable heart valve prosthesis post-dilation balloon catheter	A shaft with an inflatable balloon at its distal end intended to be used during open cardiovascular surgery to dilate the inflow ring of a sutureless cardiac (heart) valve prosthesis, after its implantation and self expansion, to facilitate valve sealing and anchoring. It typically includes a Luer connector at the proximal end and is available in a variety of sizes to fit with the valve sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08022057014825	GS1

Premarket Submissions

Submission Number	Supplement Number
P150011	000