510(k) K850888

PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV by Creative Care Systems, Inc. — Product Code LJT

K850888 is an FDA 510(k) premarket notification submitted by Creative Care Systems, Inc. for the device "PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV". The FDA issued a decision of Substantially Equivalent on May 7, 1985. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Creative Care Systems, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1985
Date Received
March 4, 1985
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