AtriClip PRO-Mini LAA Exclusion System A001578

GUDID 30840143913598

LAA Exclusion System, PROM50

ATRICURE, INC.

Ligation clip, metallic

• Primary Device ID: 30840143913598
• NIH Device Record Key: b496f39b-b03d-4b46-95cd-9c0bbcecdc09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AtriClip PRO-Mini LAA Exclusion System
• Version Model Number: PROM50
• Catalog Number: A001578
• Company DUNS: 006133784
• Company Name: ATRICURE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com

Device Dimensions

• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840143913594 [Primary]
GS1	30840143913598 [Package]; Contains: 10840143913594; Package: Box [1 Units]; In Commercial Distribution
GS1	50840143913592 [Package]; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243860

FDA Product Code

• PZX: Left Atrial Appendage Clip, Implantable

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: 2025-04-01
• Device Publish Date: 2025-03-24

On-Brand Devices [AtriClip PRO-Mini LAA Exclusion System]

• 30840143913598: LAA Exclusion System, PROM50
• 30840143913581: LAA Exclusion System, PROM45
• 30840143913574: LAA Exclusion System, PROM40
• 30840143913567: LAA Exclusion System, PROM35