AngioSculpt Evo

Basic Information

• Brand Name: AngioSculpt Evo
• Primary DI: 00813132026943
• Version / Model: 2200-3520-B
• Catalog Number: 2200-3520-B
• Company Name: Philips Image Guided Therapy Corporation
• Labeler DUNS: 118354223
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-29
• Public Version: 6
• Public Version Date: 2023-08-14
• Public Version Status: Update
• Public Device Record Key: dc80c50e-34d5-41f7-941a-80ca9eb2289d

Device Description

AngioSculpt Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating, 3.5 mm x 20 mm

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
NWX	Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
44088	Coronary angioplasty balloon catheter, cutting/scoring	A sterile, flexible tube designed for use in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery and increase myocardial perfusion, by controlled inflation of a distensible balloon at its distal tip with peripheral cutting/scoring elements (e.g., microsurgical atherotomes) intended to remove stenotic material. The device is typically placed using a guidewire and guiding catheter, and its balloon is inflated by the infusion of liquid through it tubular body. The tube and balloon are typically made of polymer materials and the cutting/scoring elements are typically made of metal [e.g., nickel-titanium alloy (Nitinol)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813132026943	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P050018	026

Device Sizes

Type	Value	Unit	Text
Balloon Diameter	3.5	Millimeter
Balloon Length	20	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry