Spartan MC 0165 MC0165ST

GUDID B489MC0165ST0

Spartan MC 0165

Spartan Micro, Inc.

Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter 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