510(k) K132841

ZYNO MEDICAL ADMINISTRATION SET by Zyno Medical, LLC — Product Code FPA

K132841 is an FDA 510(k) premarket notification submitted by Zyno Medical, LLC for the device "ZYNO MEDICAL ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on January 23, 2014. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Zyno Medical, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2014
Date Received
September 10, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type