510(k) K840240

MICROFUSE INTRAVENOUS CATHETER SET by Norton Performance Plastics Corp. — Product Code DQY

K840240 is an FDA 510(k) premarket notification submitted by Norton Performance Plastics Corp. for the device "MICROFUSE INTRAVENOUS CATHETER SET". The FDA issued a decision of Substantially Equivalent on April 17, 1984. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Norton Performance Plastics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1984
Date Received
January 20, 1984
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