FLASH Ostial System OTW OTW6012BA

GUDID M917OTW6012BA0

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 0.035" OVER-THE-WIRE, 6.0mm x 12mm

Ostial Corporation

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: M917OTW6012BA0
• NIH Device Record Key: ba24e600-f649-43d9-92d7-8a17bee7feaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLASH Ostial System OTW
• Version Model Number: OTW6012BA
• Catalog Number: OTW6012BA
• 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

Device Dimensions

• Device Size Text, specify: 0
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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)

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M917OTW6012BA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150946

FDA Product Code

• LIT: Catheter, Angioplasty, Peripheral, Transluminal

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: 2025-04-22
• Device Publish Date: 2016-09-22

On-Brand Devices [FLASH Ostial System OTW]

• M917OTW7012BA0: FLASH Ostial System, Dual Balloon Angioplasty Catheter, 0.035" OVER-THE-WIRE, 7.0mm x 12mm
• M917OTW6012BA0: FLASH Ostial System, Dual Balloon Angioplasty Catheter, 0.035" OVER-THE-WIRE, 6.0mm x 12mm