Spartan MC 0165 MC0165ST

GUDID B489MC0165ST0

Spartan MC 0165

Spartan Micro, Inc.

Vascular microcatheter

• Primary Device ID: B489MC0165ST0
• NIH Device Record Key: 80c833b2-e7cb-4343-98e6-494d4d6898ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spartan MC 0165
• Version Model Number: FG0006
• Catalog Number: MC0165ST
• Company DUNS: 080438340
• Company Name: Spartan Micro, 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: +1 949 409-8581
• Email: info@spartanmicro.com
• Phone: +1 949 409-8581
• Email: info@spartanmicro.com
• Phone: +1 949 409-8581
• Email: info@spartanmicro.com
• Phone: +1 949 409-8581
• Email: info@spartanmicro.com
• Phone: +1 949 409-8581
• Email: info@spartanmicro.com
• Phone: +1 949 409-8581
• Email: info@spartanmicro.com
• Phone: +1 949 409-8581
• Email: info@spartanmicro.com
• Phone: +1 949 409-8581
• Email: info@spartanmicro.com
• Phone: +1 949 409-8581
• Email: info@spartanmicro.com
• Phone: +1 949 409-8581
• Email: info@spartanmicro.com
• Phone: +1 949 409-8581
• Email: info@spartanmicro.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B489MC0165ST0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213451

FDA Product Code

• DQY: Catheter, Percutaneous

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: 2022-05-09
• Device Publish Date: 2022-04-29

Devices Manufactured by Spartan Micro, Inc.

• B489CWP0040150 - Spartan Center Wire: 2022-05-09 Spartan Center Wire 4mm x 15mm
• B489CWP0060300 - Spartan Center Wire: 2022-05-09 Spartan Center Wire 6mm x 30mm
• B489MC0165ST0 - Spartan MC 0165: 2022-05-09Spartan MC 0165
• B489MC0165ST0 - Spartan MC 0165: 2022-05-09 Spartan MC 0165