510(k) K053120

STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES by Excelsior Medical Corp. — Product Code FOZ

K053120 is an FDA 510(k) premarket notification submitted by Excelsior Medical Corp. for the device "STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES". The FDA issued a decision of Substantially Equivalent on December 9, 2005. 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. Excelsior Medical Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2005
Date Received
November 7, 2005
Clearance Type
Special
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