510(k) K945499

CATO FIRST PICC KIT by Catco Medical, Inc. — Product Code LJS

K945499 is an FDA 510(k) premarket notification submitted by Catco Medical, Inc. for the device "CATO FIRST PICC KIT". The FDA issued a decision of Substantially Equivalent on February 7, 1995. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Catco Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1995
Date Received
November 9, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type