Serranator

GUDID 00852495008135

The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation catheter designed to perform Percutaneous Transluminal Angioplasty (PTA) for peripheral indications. The Serranator® has a nylon semi- compliant balloon with embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to create linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.

CAGENT VASCULAR, LLC

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00852495008135
• NIH Device Record Key: 16d0f0a4-095e-417a-a4a9-7ed89eb47a0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Serranator
• Version Model Number: FGS-0346-30080
• Company DUNS: 009984330
• Company Name: CAGENT VASCULAR, LLC
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9258186875
• Email: pjohansson@cagentvascular.com
• Phone: 9258186875
• Email: pjohansson@cagentvascular.com

Device Dimensions

• Balloon Diameter: 3 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Balloon Length: 80 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852495008135 [Primary]

FDA Product Code

• PNO: Catheter, Percutaneous, Cutting/Scoring

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: 2024-11-21
• Device Publish Date: 2024-11-13

On-Brand Devices [Serranator]

• 00852495008005: The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat
• 00852495008173: The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat
• 00852495008166: The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat
• 00852495008159: The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat
• 00852495008142: The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat
• 00852495008135: The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat
• 00852495008128: The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat
• 00852495008111: The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat
• 00852495008104: The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat
• 00852495008098: The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat
• 00852495008081: The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat
• 00852495008067: The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat
• 00852495008050: The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat
• 00852495008036: The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat
• 00852495008029: The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation cat