Pronto® XL extraction catheter

GUDID M20650610

The 7F PRONTO XL extraction catheter is indicated for the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system and the removal/aspiration of thrombus from clotted synthetic dialysis grafts and arteriovenous fistulas.

Vascular Solutions, Inc.

Thrombectomy suction catheter

• Primary Device ID: M20650610
• NIH Device Record Key: 2c84b402-e73e-4c4f-932d-6427022d57f0
• Commercial Distribution Discontinuation: 2018-12-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Pronto® XL extraction catheter
• Version Model Number: 5061
• Company DUNS: 008999906
• Company Name: Vascular Solutions, 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: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M20650610 [Primary]

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-01
• Device Publish Date: 2016-09-05

On-Brand Devices [Pronto® XL extraction catheter]

• M20650910: The 14F PRONTO XL extraction catheters are indicated for the removal/aspiration of embolic mater
• M20650900: The 14F PRONTO XL extraction catheters are indicated for the removal/aspiration of embolic mater
• M20650810: The 8F PRONTO XL extraction catheters are indicated for the removal/aspiration of embolic materi
• M20650800: The 8F PRONTO XL extraction catheters are indicated for the removal/aspiration of embolic materi
• M20650610: The 7F PRONTO XL extraction catheter is indicated for the removal/aspiration of embolic material
• M20650600: The 7F PRONTO XL extraction catheter is indicated for the removal/aspiration of embolic material