CROSSTELLA OTW

Basic Information

• Brand Name: CROSSTELLA OTW
• Primary DI: 04540778162198
• Version / Model: BD-F40150LW
• Catalog Number: BD-F40150LW
• Company Name: KANEKA CORPORATION
• Labeler DUNS: 690535406
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-26
• Public Version: 4
• Public Version Date: 2019-08-09
• Public Version Status: Update
• Public Device Record Key: 2d4a6255-4087-4eed-a429-4d289fec5757

Device Description

CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46 mm).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
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	04540778162198	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K160004	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Maximum Guidewire Diameter; 0.018 inch
Device Size Text, specify			Compatible Sheath Diameter; 4 Fr
Device Size Text, specify			Rated Burst Pressure; 14 atm
Device Size Text, specify			Nominal Pressure; 8 atm
Device Size Text, specify			Shaft Diameter; 3.9 Fr
Device Size Text, specify			Catheter Working Length; 1500 mm
Device Size Text, specify			Balloon Length; 150 mm
Device Size Text, specify			Balloon Diameter; 4.0 mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry, dark place. Avoid exposure to water, direct sunlight.