510(k) K233149

CATHTONG III Tapered PICC Catheter by L&Z Us, Inc. — Product Code LJS

K233149 is an FDA 510(k) premarket notification submitted by L&Z Us, Inc. for the device "CATHTONG III Tapered PICC Catheter". The FDA issued a decision of Substantially Equivalent on December 1, 2023. 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. L&Z Us, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2023
Date Received
September 27, 2023
Clearance Type
Special
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