510(k) K830755

I.V. SETS WALRUS BRAND VARIOUS CONFIGUR- by Medical Parameters, Inc. — Product Code FPA

K830755 is an FDA 510(k) premarket notification submitted by Medical Parameters, Inc. for the device "I.V. SETS WALRUS BRAND VARIOUS CONFIGUR-". The FDA issued a decision of Substantially Equivalent on April 28, 1983. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Medical Parameters, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1983
Date Received
March 10, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type