510(k) Report

Devices descending from K131038

3 later devices reach Nmi Picc Maximal Barrier Nursing Kits through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142616PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.2014213
+2K163452PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.201715
+3K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with…Spectrum Vascular20250—