510(k) K920133

VERSACATH SELECTALUMEN INNER CATHETER by Menlo Care, Inc. — Product Code FOZ

K920133 is an FDA 510(k) premarket notification submitted by Menlo Care, Inc. for the device "VERSACATH SELECTALUMEN INNER CATHETER". The FDA issued a decision of Substantially Equivalent on March 26, 1992. 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 26, 1992
Date Received
January 13, 1992
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