ClearView MV Atrial Depressor

Basic Information

• Brand Name: ClearView MV Atrial Depressor
• Primary DI: 00818354013955
• Version / Model: 001-400-005
• Company Name: ATRICURE, INC.
• Labeler DUNS: 006133784
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 5f986dab-fbd7-4f11-a066-5647a2cbf72b

Device Description

ClearView MV Atrial Depressor

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: Yes
• 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
DTS	Sucker, Cardiotomy Return, Cardiopulmonary Bypass	Cardiovascular	870.4420	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35313	Cardiac retractor	A hand-held manual surgical instrument designed to separate or draw aside the edges of an incision in the heart, various anatomical structures of the heart (e.g., an atrium or aortic valve), or the entire organ. It consists of a handle proximally and a wire frame-like blade, with no sharp edges, that can have various shapes and angles at the distal tip. It is made of high-grade stainless steel and may have a synthetic material for the handle (e.g., Tufnol). This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818354013955	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K053021	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place