Serranator

Basic Information

• Brand Name: Serranator
• Primary DI: 00852495008128
• Version / Model: FGS-0346-30040
• Company Name: CAGENT VASCULAR, LLC
• Labeler DUNS: 009984330
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-13
• Public Version: 1
• Public Version Date: 2024-11-21
• Public Version Status: New
• Public Device Record Key: 9fa8bc69-582d-4687-be13-69f56e889a47

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PNO	Catheter, Percutaneous, Cutting/Scoring	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17184	Peripheral angioplasty balloon catheter, basic	A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852495008128	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Balloon Diameter	3	Millimeter
Balloon Length	40	Millimeter