PolarCath

Basic Information

• Brand Name: PolarCath
• Primary DI: B479NC30000010
• Version / Model: NC3000001
• Company Name: Nucryo Vascular
• Labeler DUNS: 045796615
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-19
• Public Version: 2
• Public Version Date: 2019-08-09
• Public Version Status: Update
• Public Device Record Key: debdda18-bc87-4e12-830d-df9de9f5b199

Device Description

PolarCath nitrous oxide cartridge for use with PolarCath peripheral dilation system

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQY	Catheter, Percutaneous	Cardiovascular	870.1250	2
LIT	Catheter, Angioplasty, Peripheral, Transluminal	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	B479NC30000010	HIBCC
Package	B479NC30000011	HIBCC	BOX	10	In Commercial Distribution