APRO 55 Intermediate Catheter APRO-55IC-137

GUDID 00850014025281

APRO 55 Catheter, Hooped Configuration

Alembic, LLC

Vascular guide-catheter, single-use

• Primary Device ID: 00850014025281
• NIH Device Record Key: c260d77f-980d-44c8-97d2-ea5f8ccbac88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APRO 55 Intermediate Catheter
• Version Model Number: FG-01681-N37-IC
• Catalog Number: APRO-55IC-137
• 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	00850014025281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250962

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: 2025-07-08
• Device Publish Date: 2025-06-30

On-Brand Devices [APRO 55 Intermediate Catheter]

• 00850014025090: APRO-55IC-137
• 00850014025083: APRO-55IC-125
• 00850014025281: APRO 55 Catheter, Hooped Configuration
• 00850014025243: APRO 55 Catheter, Hoop Configuration