510(k) K040163

MICROVASCULAR ANASTOMOTIC DEVICE by Synovis Micro Companies Alliance, Inc. — Product Code MVR

K040163 is an FDA 510(k) premarket notification submitted by Synovis Micro Companies Alliance, Inc. for the device "MICROVASCULAR ANASTOMOTIC DEVICE". The FDA issued a decision of Substantially Equivalent on April 16, 2004. The device falls under product code MVR (Device, Anastomotic, Microvascular), a Class II device regulated under 21 CFR 878.4300. Synovis Micro Companies Alliance, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2004
Date Received
January 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Anastomotic, Microvascular
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type