510(k) K821996

LEONARD PERIPHERAL VENOUS PRESSURE CATH by Norton Performance Plastics Corp. — Product Code DYG

K821996 is an FDA 510(k) premarket notification submitted by Norton Performance Plastics Corp. for the device "LEONARD PERIPHERAL VENOUS PRESSURE CATH". The FDA issued a decision of Substantially Equivalent on July 30, 1982. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Norton Performance Plastics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1982
Date Received
July 7, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Flow Directed
Device Class
Class II
Regulation Number
870.1240
Review Panel
CV
Submission Type