PressureWire™

Basic Information

• Brand Name: PressureWire™
• Primary DI: 05414734055796
• Version / Model: C12308
• Catalog Number: C12308
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-09
• Public Version: 7
• Public Version Date: 2022-11-07
• Public Version Status: Update
• Public Device Record Key: 06d6c60d-3620-4163-9f66-0a17e7b2b04e

Device Description

Guidewire Mounted Sensor

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
DQX	WIRE, GUIDE, CATHETER	Cardiovascular	870.1330	2
DXO	TRANSDUCER, PRESSURE, CATHETER TIP	Cardiovascular	870.2870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35094	Cardiac/peripheral vascular guidewire, single-use	A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.	No	Active
15071	Catheter-tip transducer, pressure	A device intended to be incorporated into the distal end of a catheter (not included) to measure pressure. It typically consists of a pressure sensor (e.g., a flexible membrane or diaphragm) and a means to convert the detected pressure into electronic signals or possibly ultrasonic signals which are transmitted via a cable or wireless to an external parent device (e.g., a manometer) that processes the signals and displays the results. It is used for invasive measurement of pressure in places such as the central and/or peripheral vasculature, cranium, uterus (typically during labour), pleura, and also in the urinary bladder/urethra (e.g., during urodynamic tests). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05414734055796	GS1
Package	15414734055793	GS1		5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140466	000

Device Sizes

Type	Value	Unit	Text
Length	300	Centimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -13 – 140 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -25 – 60 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry. Keep away from sunlight.