510(k) K112874

EZ VEIN INFLATABLE TOURNIQUET by Dominion Medical Devices, LLC — Product Code KCY

K112874 is an FDA 510(k) premarket notification submitted by Dominion Medical Devices, LLC for the device "EZ VEIN INFLATABLE TOURNIQUET". The FDA issued a decision of Substantially Equivalent on October 17, 2011. The device falls under product code KCY (Tourniquet, Pneumatic), a Class I device regulated under 21 CFR 878.5910.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2011
Date Received
September 30, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tourniquet, Pneumatic
Device Class
Class I
Regulation Number
878.5910
Review Panel
SU
Submission Type