Balloon Catheter BC0210M

GUDID 00842429106563

Scepter Mini

MICROVENTION INC.

Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 00842429106563
• NIH Device Record Key: 58923b55-3c74-41f6-875c-452c4bba56ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balloon Catheter
• Version Model Number: BC0210M-US
• Catalog Number: BC0210M
• Company DUNS: 003263105
• Company Name: MICROVENTION 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: true
• 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(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842429106563 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182829

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: 2022-06-22
• Device Publish Date: 2022-06-14

On-Brand Devices [Balloon Catheter]

• 00842429106563: Scepter Mini
• 00842429103418: Scepter XC
• 00842429103401: Scepter C
• 00842429103395: Scepter C
• 00842429103388: Scepter C
• 00842429106945: Scepter XC
• 00842429106907: Scepter C
• 00842429106891: Scepter C
• 00842429106884: Scepter C