7 Fr PV-Catheter

Basic Information

• Brand Name: 7 Fr PV-Catheter
• Primary DI: 08719327737347
• Version / Model: CA-71123-PL
• Catalog Number: CDL018
• Company Name: CD Leycom
• Labeler DUNS: 414947457
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-20
• Public Version: 1
• Public Version Date: 2023-09-28
• Public Version Status: New
• Public Device Record Key: 997378b2-1bba-4cf6-b0e0-bdac17cd5fa7

Device Description

7 Fr PV-Loop catheter with 12 mm electrode spacing

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	870.1200	2
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11434	Intracardiac catheter-tip electrode	An electrical conductor located at one end of an appropriate flexible catheter (not included) which is inserted into the chambers of the heart in order for the electrode to detect the presence of certain indicators to measure cardiac output. The relayed signals from the electrode can help the operator determine the presence of left-to-right heart shunt. The electrical conductor may also be used to characterize the electrical activity of the heart. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08719327737347	GS1

Premarket Submissions

Submission Number	Supplement Number
K030524	000