510(k) K150448

NMI PICC III and NMI PICC IV by Navilyst Medical, Inc. — Product Code LJS

K150448 is an FDA 510(k) premarket notification submitted by Navilyst Medical, Inc. for the device "NMI PICC III and NMI PICC IV". The FDA issued a decision of Substantially Equivalent on March 19, 2015. 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
March 19, 2015
Date Received
February 20, 2015
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