510(k) K841679

VASCULAR-ACCESS-PORT WITHDRAWL-BLOOD by Norfolk Medical Products, Inc. — Product Code LJT

K841679 is an FDA 510(k) premarket notification submitted by Norfolk Medical Products, Inc. for the device "VASCULAR-ACCESS-PORT WITHDRAWL-BLOOD". The FDA issued a decision of Substantially Equivalent on June 28, 1984. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Norfolk Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1984
Date Received
April 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type