Volt™ K-VOLT-HDV-S

GUDID 05415067055927

PFA Kit

ST. JUDE MEDICAL, INC.

Cardiac irreversible electroporation system catheter

• Primary Device ID: 05415067055927
• NIH Device Record Key: b7da4736-9693-4da9-bedb-f949be69c489
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Volt™
• Version Model Number: K-VOLT-HDV-S
• Catalog Number: K-VOLT-HDV-S
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted from -20°C to 50°C and relative humidity of 10% to 90%, Keep dry, keep away from sunlight, Protect from heat and radioactive sources.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted from -20°C to 50°C and relative humidity of 10% to 90%, Keep dry, keep away from sunlight, Protect from heat and radioactive sources.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted from -20°C to 50°C and relative humidity of 10% to 90%, Keep dry, keep away from sunlight, Protect from heat and radioactive sources.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted from -20°C to 50°C and relative humidity of 10% to 90%, Keep dry, keep away from sunlight, Protect from heat and radioactive sources.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067055927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P250022

FDA Product Code

• QZI: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-14
• Device Publish Date: 2026-01-06

On-Brand Devices [Volt™]

• 05415067055934: PFA Kit
• 05415067055927: PFA Kit
• 05415067055910: PFA Kit
• 05415067055903: PFA Kit