510(k) K121182

VIALOK NON-VENTED by Yukon Medical, LLC — Product Code LHI

K121182 is an FDA 510(k) premarket notification submitted by Yukon Medical, LLC for the device "VIALOK NON-VENTED". The FDA issued a decision of Substantially Equivalent on May 3, 2012. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Yukon Medical, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2012
Date Received
April 18, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type