510(k) K833825

MULTI-LUMEN INTRAVENOUS INFUSION CATH by Medical Parameters, Inc. — Product Code DQY

K833825 is an FDA 510(k) premarket notification submitted by Medical Parameters, Inc. for the device "MULTI-LUMEN INTRAVENOUS INFUSION CATH". The FDA issued a decision of Substantially Equivalent on January 10, 1984. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Medical Parameters, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1984
Date Received
November 2, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type