510(k) K022754

S&T SINGLE USE MICRO ANASTOMOSIS CLAMP by S & T AG — Product Code DXC

K022754 is an FDA 510(k) premarket notification submitted by S & T AG for the device "S&T SINGLE USE MICRO ANASTOMOSIS CLAMP". The FDA issued a decision of Substantially Equivalent on October 16, 2002. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. S & T AG has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2002
Date Received
August 19, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type