510(k) K131942

NMI PICC III CATHETER, NMI HPICC III CATHETER by Navilyst Medical, Inc. — Product Code LJS

K131942 is an FDA 510(k) premarket notification submitted by Navilyst Medical, Inc. for the device "NMI PICC III CATHETER, NMI HPICC III CATHETER". The FDA issued a decision of Substantially Equivalent on July 31, 2013. 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. Navilyst Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2013
Date Received
June 27, 2013
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