510(k) K830788

CENTRAL VEIN CATHERIZATION KIT-14-690- by Norton Performance Plastics Corp. — Product Code DQO

K830788 is an FDA 510(k) premarket notification submitted by Norton Performance Plastics Corp. for the device "CENTRAL VEIN CATHERIZATION KIT-14-690-". The FDA issued a decision of Substantially Equivalent on April 30, 1983. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Norton Performance Plastics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1983
Date Received
March 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type