EverCross™

Basic Information

• Brand Name: EverCross™
• Primary DI: 00763000184469
• Version / Model: AB35W06120080
• Company Name: EV3, INC
• Labeler DUNS: 117446916
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-18
• Public Version: 3
• Public Version Date: 2022-09-22
• Public Version Status: Update
• Public Device Record Key: 4c97a3a0-6a7d-441e-8044-435e7d677d1d

Device Description

PTA AB35W06120080 EVERCROSS 035 V09

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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LIT	Catheter, angioplasty, peripheral, transluminal	Cardiovascular	870.1250	2
DQY	Catheter, percutaneous	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	00763000184469	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K110319	000

Device Sizes

Type	Value	Unit	Text
Length	80.0	Centimeter
Device Size Text, specify			0.035 IN Max. Guidewire
Device Size Text, specify			120 MM Balloon Length
Catheter Gauge	5.0	French
Device Size Text, specify			6 MM Balloon Diameter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: Store the EverCross catheter in a cool, dry, and dark place, at room temperature. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight