APRO 70 SwiftCatheter APRO-70-125

GUDID 00850014025113

Alembic, LLC

Thrombectomy suction catheter

• Primary Device ID: 00850014025113
• NIH Device Record Key: bbf00f3d-1bdd-4c17-ba32-cf69d35cbe34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APRO 70 SwiftCatheter
• Version Model Number: FG-02133-125-AC
• Catalog Number: APRO-70-125
• Company DUNS: 065914268
• Company Name: Alembic, LLC
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014025113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243287

FDA Product Code

• NRY: Catheter, Thrombus Retriever

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: 2025-03-12
• Device Publish Date: 2025-03-04

Devices Manufactured by Alembic, LLC

• 00850014025113 - APRO 70 SwiftCatheter: 2025-03-12
• 00850014025113 - APRO 70 SwiftCatheter: 2025-03-12
• 00850014025120 - APRO 70 Swift Catheter: 2025-03-12
• 00850014025229 - APRO 70 Swift Catheter: 2025-03-12
• 00850014025267 - APRO 70 Swift Catheter: 2025-03-12
• 00850014025069 - APRO 70 Catheter: 2024-07-30
• 00850014025052 - APRO 55 Catheter: 2024-04-16
• 00850014025083 - APRO 55 Intermediate Catheter: 2024-04-16
• 00850014025090 - APRO 55 Intermediate Catheter: 2024-04-16