FLASH MINI Ostial System OCB3008BA

GUDID M917OCB3008BA0

FLASH MINI Ostial System, Dual Balloon Angioplasty Catheter, 3.0mm x 8mm

OSTIAL CORPORATION

Coronary angioplasty balloon catheter, basic

• Primary Device ID: M917OCB3008BA0
• NIH Device Record Key: 586f18d1-f17a-4071-bc73-44a69c689508
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLASH MINI Ostial System
• Version Model Number: OCB3008BA
• Catalog Number: OCB3008BA
• Company DUNS: 078708447
• Company Name: OSTIAL CORPORATION
• 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: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.com
• Phone: 1-844-352-7411
• Email: info@ostialcorp.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 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 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 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location at room temperature (~23°C)

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M917OCB3008BA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131450

FDA Product Code

• LOX: Catheters, Transluminal Coronary Angioplasty, Percutaneous

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: 2019-10-07
• Device Publish Date: 2016-09-22

On-Brand Devices [FLASH MINI Ostial System]

• M917OCB4508BA0: FLASH MINI Ostial System, Dual Balloon Angioplasty Catheter, 4.5mm x 8mm
• M917OCB4008BA0: FLASH MINI Ostial System, Dual Balloon Angioplasty Catheter, 4.0mm x 8mm
• M917OCB3508BA0: FLASH MINI Ostial System, Dual Balloon Angioplasty Catheter, 3.5mm x 8mm
• M917OCB3008BA0: FLASH MINI Ostial System, Dual Balloon Angioplasty Catheter, 3.0mm x 8mm