FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX

Clamp, Vascular

RMDS, INC.

The following data is part of a premarket notification filed by Rmds, Inc. with the FDA for Favp: Femoral Artery Vascular Pad - Model Number Pad2ek-01, Pad2ek-2x, Pad5ek-r, Pad5ek-rx, Pad6ek-f And Pad6ek-fx.

Pre-market Notification Details

• Device ID: K964663
• 510k Number: K964663
• Device Name: FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX
• 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: 1997-12-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20815614021020	K964663	000
10815614020279	K964663	000
10815614020293	K964663	000
10815614020309	K964663	000
10815614020316	K964663	000
10815614020323	K964663	000
10815614020330	K964663	000
20815614021006	K964663	000
10815614021016	K964663	000
20815614021037	K964663	000
20815614021051	K964663	000
20815614021068	K964663	000
20815614021075	K964663	000
10815614020255	K964663	000