AlphaVac

GUDID H787253020

AlphaVac Multipurpose Mechanical Aspiration F18 85

Angiodynamics, Inc.

Thrombectomy suction catheter

• Primary Device ID: H787253020
• NIH Device Record Key: 8ac58c48-cf8a-4797-be1d-1f12e4715e4c
• Commercial Distribution Discontinuation: 2024-09-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AlphaVac
• Version Model Number: 25-302
• Company DUNS: 079252781
• Company Name: Angiodynamics, 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com

Device Dimensions

• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H787253020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213388

FDA Product Code

• QEZ: Aspiration thrombectomy catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2024-09-30
• Device Publish Date: 2022-04-12

On-Brand Devices [AlphaVac]

• 15051684025942: AlphaVac Multipurpose Mechanical Aspiration 25F/C20
• 15051684025959: AlphaVac Multipurpose Mechanical Aspiration 25F/C180
• 15051684025966: AlphaVac Multipurpose Mechanical Aspiration F18 85
• H787253020: AlphaVac Multipurpose Mechanical Aspiration F18 85
• H787253010: AlphaVac Multipurpose Mechanical Aspiration 25F/C180
• H787253000: AlphaVac Multipurpose Mechanical Aspiration 25F/C20