FLASH Ostial System OCB5014BA

GUDID M917OCB5014BA0

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 5.0mm x 12mm

OSTIAL CORPORATION

Coronary angioplasty balloon catheter, basic

• Primary Device ID: M917OCB5014BA0
• NIH Device Record Key: fd00c644-4d65-4e99-bba4-12a03ac5fad6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLASH Ostial System
• Version Model Number: OCB5014BA
• Catalog Number: OCB5014BA
• 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
• Phone: 1-844-352-7411
• Email: customerservice@vergemedical.com
• Phone: 1-844-352-7411
• Email: customerservice@vergemedical.com
• Phone: 1-844-352-7411
• Email: customerservice@vergemedical.com
• Phone: 1-844-352-7411
• Email: customerservice@vergemedical.com
• Phone: 1-844-352-7411
• Email: customerservice@vergemedical.com
• Phone: 1-844-352-7411
• Email: customerservice@vergemedical.com
• Phone: 1-844-352-7411
• Email: customerservice@vergemedical.com
• Phone: 1-844-352-7411
• Email: customerservice@vergemedical.com
• Phone: 1-844-352-7411
• Email: customerservice@vergemedical.com
• Phone: 1-844-352-7411
• Email: customerservice@vergemedical.com
• Phone: 1-844-352-7411
• Email: customerservice@vergemedical.com
• Phone: 1-844-352-7411
• Email: customerservice@vergemedical.com

Device Dimensions

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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)
• 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	M917OCB5014BA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113775

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: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-22

On-Brand Devices [FLASH Ostial System]

• M917OCB5019BA0: FLASH Ostial System, Dual Balloon Angioplasty Catheter, 5.0mm x 17mm
• M917OCB5014BA0: FLASH Ostial System, Dual Balloon Angioplasty Catheter, 5.0mm x 12mm
• M917OCB4514BA0: FLASH Ostial System, Dual Balloon Angioplasty Catheter, 4.5mm x 12mm
• M917OCB4014BA0: FLASH Ostial System, Dual Balloon Angioplasty Catheter, 4.0mm x 12mm
• M917OAB7019BA0: FLASH Ostial System, Dual Balloon Angioplasty Catheter, 7.0mm x 17mm
• M917OAB6019BA0: FLASH Ostial System, Dual Balloon Angioplasty Catheter, 6.0mm x 17mm
• M917OAB6014BA0: FLASH Ostial System, Dual Balloon Angioplasty Catheter, 6.0mm x 12mm