Therapy™ A700455

GUDID 05415067004550

Ablation Catheter

IRVINE BIOMEDICAL, INC.

Cardiac radio-frequency ablation system catheter

• Primary Device ID: 05415067004550
• NIH Device Record Key: 569bb282-da26-482c-841b-ebbf75d9c0c0
• Commercial Distribution Discontinuation: 2017-12-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Therapy™
• Version Model Number: Cool Path™ Duo SP
• Catalog Number: A700455
• Company DUNS: 926346966
• Company Name: IRVINE BIOMEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Catheter Gauge: 7 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry location

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067004550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P110016

FDA Product Code

• OAD: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-28
• Device Publish Date: 2014-10-31

On-Brand Devices [Therapy™ ]

• 05415067019875: Cool Path™
• 05415067004574: Ablation Catheter
• 05415067004567: Ablation Catheter
• 05415067004550: Ablation Catheter
• 05415067004543: Ablation Catheter
• 05414734310680: Ablation Catheter
• 05414734310673: Ablation Catheter
• 05414734310666: Ablation Catheter
• 05414734310659: Ablation Catheter
• 05414734308595: Cool Path™
• 05414734308588: Cool Path™
• 05414734308571: Cool Path™
• 05414734308564: Cool Path™
• 05414734308403: IBI-83726
• 05414734308397: Ablation Catheter
• 05414734308380: IBI-83724
• 05414734308359: Ablation Catheter
• 05414734308342: IBI-83720
• 05414734308335: IBI-83719
• 05414734307598: IBI-83445
• 05414734307581: 8mm Tip Thermistor Ablation Catheter
• 05414734307567: IBI-83442
• 05414734307550: 8mm Tip Thermistor Ablation Catheter
• 05414734307024: Ablation Catheter
• 05414734307017: Dual 8™
• 05414734307000: Dual-8™
• 05414734306997: Dual-8™
• 05414734306980: Dual-8™
• 05414734306973: Ablation Catheter
• 05414734306959: IBI-83368
• 05414734306942: Ablation Catheter
• 05414734306935: IBI-83366
• 05414734306928: IBI-83365
• 05414734306911: IBI-83364
• 05414734306737: Cool Path™
• 05414734306720: Cool Path™
• 05414734306713: Cool Path™
• 05414734306706: Cool Path™