FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15

Clamp, Vascular

RMDS, INC.

The following data is part of a premarket notification filed by Rmds, Inc. with the FDA for Favc: Femoral Artery Vascular Clamp - Model Number Rmds 1000-15, Rmds 1000-20, Rmds 2000-15, Rmds 2000-20, Rmds 3000-15.

Pre-market Notification Details

• Device ID: K964662
• 510k Number: K964662
• Device Name: FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15
• Classification: Clamp, Vascular
• Applicant: RMDS, INC. 1208 SE 104TH AVE. Vancouver, WA 98664 -4740
• Contact: Delbert L Rice
• Correspondent: Delbert L Rice; RMDS, INC. 1208 SE 104TH AVE. Vancouver, WA 98664 -4740
• Product Code: DXC
• CFR Regulation Number: 870.4450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-11-21
• Decision Date: 1997-02-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10815614020637	K964662	000
10815614020620	K964662	000