510(k) K953120

VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE by Vital Signs, Inc. — Product Code FOZ

K953120 is an FDA 510(k) premarket notification submitted by Vital Signs, Inc. for the device "VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE". The FDA issued a decision of Substantially Equivalent on December 13, 1995. 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. Vital Signs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1995
Date Received
July 5, 1995
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