MVR · Class II · 21 CFR 878.4300

FDA Product Code MVR: Device, Anastomotic, Microvascular

Leading manufacturers include Synovis Life Technologies, Inc., Baxter/ Synovis Micro Companies Alliance, Inc. and Vioptix, Inc..

9
Total
9
Cleared
85d
Avg days
1986
Since

FDA 510(k) Cleared Device, Anastomotic, Microvascular Devices (Product Code MVR)

9 devices
1–9 of 9
Cleared Sep 06, 2019
Gem FlowCoupler System
K190499
Baxter/ Synovis Micro Companies Alliance, Inc.
General & Plastic Surgery · 189d
Cleared Jul 09, 2019
Gem FlowCoupler System
K191252
Baxter/ Synovis Micro Companies Alliance, Inc.
General & Plastic Surgery · 61d
Cleared Jan 16, 2015
GEM Flow COUPLER Device and System
K143589
Synovis Life Technologies, Inc.
General & Plastic Surgery · 29d
Cleared Sep 16, 2014
GEM Flow COUPLER Device and System
K142309
Synovis Life Technologies, Inc.
General & Plastic Surgery · 28d
Cleared Oct 22, 2013
GEM FLOW COUPLER DEVICE AND SYSTEM
K132727
Synovis Life Technologies, Inc.
General & Plastic Surgery · 49d
Cleared Feb 01, 2010
GEM FLOW COUPLER DEVICE AND SYSTEM
K093310
Synovis Micro Companies Alliance, Inc.
General & Plastic Surgery · 102d
Cleared Apr 17, 2009
VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM
K090679
Vioptix, Inc.
General & Plastic Surgery · 32d
Cleared Dec 04, 1986
3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)
K861985
3M Company
General & Plastic Surgery · 196d

About Product Code MVR - Regulatory Context