510(k) K932071

I.V. START KIT by Clinipad Corp. — Product Code FOZ

K932071 is an FDA 510(k) premarket notification submitted by Clinipad Corp. for the device "I.V. START KIT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on February 17, 1994. 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. Clinipad Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
February 17, 1994
Date Received
April 28, 1993
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