VSI Micro-Introducer Kit

GUDID M2067214V1

VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inch or 0.038 inch guidewire or catheter into the vascular system following a small gauge needle stick.

Vascular Solutions, Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: M2067214V1
• NIH Device Record Key: 966eb515-1f40-48ba-9be8-2ffa4aa499b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VSI Micro-Introducer Kit
• Version Model Number: 7214V
• 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: true
• 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
• 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
• 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

• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 2.3 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M2067214V0 [Primary]
HIBCC	M2067214V1 [Package]; Contains: M2067214V0; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101604

FDA Product Code

• DYB: Introducer, 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: 5
• Public Version Date: 2019-11-11
• Device Publish Date: 2016-09-05

On-Brand Devices [VSI Micro-Introducer Kit]

• M2069222V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2069221V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2069220V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2069219V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2069218V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2069217V0: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2069211V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2069210V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2069209V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2069208V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2069203V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2069202V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2069201V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2069200V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067280V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067274V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067273X0: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067273V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067272X0: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067272V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067271V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067270V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067269V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067268V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067267X0: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067267V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067266V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067265V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067264V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067263V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067262V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067261V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067260V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067259V0: 7259V
• M2067256X0: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067256V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067255X0: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067255V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067254V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067253V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067250X0: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067250V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067249V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067248V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067247V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067246V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067245V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067244V1: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067243V0: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc
• M2067242V0: VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inc