Plato PL17-160-000

GUDID 00818075010455

Microcatheter straight tip

SCIENTIA VASCULAR LLC

Vascular microcatheter

• Primary Device ID: 00818075010455
• NIH Device Record Key: ed6ccaed-2296-4ce5-b342-a9c13bec8591
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plato
• Version Model Number: 17-160-000
• Catalog Number: PL17-160-000
• Company DUNS: 011234178
• Company Name: SCIENTIA VASCULAR LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com

Device Dimensions

• Catheter Inner Diameter: 0.017 Inch
• Catheter Working Length: 160 Centimeter
• Outer Diameter: 0.57 Millimeter
• Pressure: 300 Pound per Square Inch
• Catheter Inner Diameter: 0.017 Inch
• Catheter Working Length: 160 Centimeter
• Outer Diameter: 0.57 Millimeter
• Pressure: 300 Pound per Square Inch
• Catheter Inner Diameter: 0.017 Inch
• Catheter Working Length: 160 Centimeter
• Outer Diameter: 0.57 Millimeter
• Pressure: 300 Pound per Square Inch
• Catheter Inner Diameter: 0.017 Inch
• Catheter Working Length: 160 Centimeter
• Outer Diameter: 0.57 Millimeter
• Pressure: 300 Pound per Square Inch
• Catheter Inner Diameter: 0.017 Inch
• Catheter Working Length: 160 Centimeter
• Outer Diameter: 0.57 Millimeter
• Pressure: 300 Pound per Square Inch
• Catheter Inner Diameter: 0.017 Inch
• Catheter Working Length: 160 Centimeter
• Outer Diameter: 0.57 Millimeter
• Pressure: 300 Pound per Square Inch
• Catheter Inner Diameter: 0.017 Inch
• Catheter Working Length: 160 Centimeter
• Outer Diameter: 0.57 Millimeter
• Pressure: 300 Pound per Square Inch
• Catheter Inner Diameter: 0.017 Inch
• Catheter Working Length: 160 Centimeter
• Outer Diameter: 0.57 Millimeter
• Pressure: 300 Pound per Square Inch
• Catheter Inner Diameter: 0.017 Inch
• Catheter Working Length: 160 Centimeter
• Outer Diameter: 0.57 Millimeter
• Pressure: 300 Pound per Square Inch
• Catheter Inner Diameter: 0.017 Inch
• Catheter Working Length: 160 Centimeter
• Outer Diameter: 0.57 Millimeter
• Pressure: 300 Pound per Square Inch
• Catheter Inner Diameter: 0.017 Inch
• Catheter Working Length: 160 Centimeter
• Outer Diameter: 0.57 Millimeter
• Pressure: 300 Pound per Square Inch
• Catheter Inner Diameter: 0.017 Inch
• Catheter Working Length: 160 Centimeter
• Outer Diameter: 0.57 Millimeter
• Pressure: 300 Pound per Square Inch
• Catheter Inner Diameter: 0.017 Inch
• Catheter Working Length: 160 Centimeter
• Outer Diameter: 0.57 Millimeter
• Pressure: 300 Pound per Square Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818075010455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210601

FDA Product Code

• DQY: Catheter, 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: 2
• Public Version Date: 2023-09-18
• Device Publish Date: 2023-01-26

On-Brand Devices [Plato]

• 00818075010080: Catheter
• 00818075010479: Microcatheter 90degree tip
• 00818075010462: Microcatheter 45degree tip
• 00818075010455: Microcatheter straight tip