510(k) K944968

LANDMARK MIDLINE CATHETER by Menlo Care, Inc. — Product Code FOZ

K944968 is an FDA 510(k) premarket notification submitted by Menlo Care, Inc. for the device "LANDMARK MIDLINE CATHETER". The FDA issued a decision of Substantially Equivalent on March 29, 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. Menlo Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1995
Date Received
October 11, 1994
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