FOGARTY 6MM SOFTJAW CLIP

Clamp, Vascular

AMERICAN EDWARDS LABORATORIES

The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Fogarty 6mm Softjaw Clip.

Pre-market Notification Details

• Device ID: K832554
• 510k Number: K832554
• Device Name: FOGARTY 6MM SOFTJAW CLIP
• Classification: Clamp, Vascular
• Applicant: AMERICAN EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DXC
• CFR Regulation Number: 870.4450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-08-01
• Decision Date: 1983-09-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00690103044195	K832554	000
00690103044188	K832554	000