510(k) K944685

CATO FIRST PICC-DUAL LUMEN by Catco Medical, Inc. — Product Code LJS

K944685 is an FDA 510(k) premarket notification submitted by Catco Medical, Inc. for the device "CATO FIRST PICC-DUAL LUMEN". The FDA issued a decision of Substantially Equivalent on March 31, 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
March 31, 1995
Date Received
September 22, 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