Plato PL17-160-000

GUDID 00818075010455

Microcatheter straight tip

SCIENTIA VASCULAR LLC

Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter 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