510(k) K952256

PICC LINE KIT by Medi-Flex Hospital Products, Inc. — Product Code FOZ

K952256 is an FDA 510(k) premarket notification submitted by Medi-Flex Hospital Products, Inc. for the device "PICC LINE KIT". The FDA issued a decision of Substantially Equivalent on July 31, 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. Medi-Flex Hospital Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1995
Date Received
May 15, 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