Paladin PD-5530-140-2

GUDID 00851616007293

The Paladin Carotid PTA Balloon System with Integrated Embolic Protection (IEP), is indicated for Percutaneous Transluminal Angioplasty (PTA) in the carotid arteries with capture and removal of embolic material

Contego Medical, Inc.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00851616007293
• NIH Device Record Key: f29a3578-f3f4-4bcc-940f-a732209dd544
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paladin
• Version Model Number: 5.5x30
• Catalog Number: PD-5530-140-2
• Company DUNS: 048268128
• Company Name: Contego Medical, Inc.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851616007293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181128

FDA Product Code

• LIT: Catheter, Angioplasty, Peripheral, Transluminal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-13
• Device Publish Date: 2023-09-05

On-Brand Devices [Paladin]

• 00851616007309: The Paladin Carotid PTA Balloon System with Integrated Embolic Protection (IEP), is indicated fo
• 00851616007002: The Paladin Carotid PTA Balloon System with Integrated Embolic Protection (IEP), is indicated fo
• 00851616007477: The Paladin Carotid PTA Balloon System with Integrated Embolic Protection (IEP), is indicated fo
• 00851616007293: The Paladin Carotid PTA Balloon System with Integrated Embolic Protection (IEP), is indicated fo