CavaClear

Basic Information

• Brand Name: CavaClear
• Primary DI: 00813132022969
• Version / Model: 500-514
• Catalog Number: 500-514
• 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: 2022-03-03
• Public Version: 1
• Public Version Date: 2022-03-11
• Public Version Status: New
• Public Device Record Key: 96ca2043-59d5-4132-8acc-ef736f504d45

Device Description

14F CavaClear Laser Sheath

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
QRJ	Laser-Powered Inferior Vena Cava Filter Retrieval Catheter	Cardiovascular	870.5125	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45162	Vena cava filter extraction/repositioning kit	A collection of sterile devices designed to perform the percutaneous retrieval or repositioning of an implanted inferior vena cava (IVC) filter. It will typically contain various dedicated catheters with dilating, pushing, and retrieval functions (e.g., gripping claws, loop/lasso) and devices such as needles and guide wires. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813132022969	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN210024	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry; Keep away from sunlight
• Type: Storage Environment Temperature
• Temperature Range: – 140 Degrees Fahrenheit