510(k) K042504

CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER by Myco Medical Supplies, Inc. — Product Code FOZ

K042504 is an FDA 510(k) premarket notification submitted by Myco Medical Supplies, Inc. for the device "CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER". The FDA issued a decision of Substantially Equivalent on January 19, 2006. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Myco Medical Supplies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2006
Date Received
September 15, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type