ATRIUM FLIXENE GRAFT

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

ATRIUM MEDICAL CORP.

The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Flixene Graft.

Pre-market Notification Details

• Device ID: K060124
• 510k Number: K060124
• Device Name: ATRIUM FLIXENE GRAFT
• Classification: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
• Applicant: ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051
• Contact: Karen Hall
• Correspondent: Karen Hall; ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051
• Product Code: DSY
• CFR Regulation Number: 870.3450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-01-18
• Decision Date: 2006-03-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00650862250572	K060124	000
00650862250541	K060124	000
00650862250534	K060124	000