510(k) K932841

PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS by Pharmacia Deltec, Inc. — Product Code LJT

K932841 is an FDA 510(k) premarket notification submitted by Pharmacia Deltec, Inc. for the device "PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS". The FDA issued a decision of Substantially Equivalent on January 5, 1994. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Pharmacia Deltec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1994
Date Received
June 11, 1993
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