APRO 70 Swift Catheter APRO-70-132

GUDID 00850014025229

Alembic, LLC

Vascular guide-catheter, single-use

• Primary Device ID: 00850014025229
• NIH Device Record Key: 86e9bc75-892b-4a10-8ace-a38b0048ddb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APRO 70 Swift Catheter
• Version Model Number: FG-02133-132-IC
• Catalog Number: APRO-70-132
• 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	00850014025229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243297

FDA Product Code

• QJP: Catheter, Percutaneous, Neurovasculature

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

On-Brand Devices [APRO 70 Swift Catheter]

• 00850014025267: FG-02133-132-AC
• 00850014025229: FG-02133-132-IC
• 00850014025120: FG-02133-135-AC