Navilyst Medical, Inc

FDA Regulatory Profile

Summary

Total Recalls
73
510(k) Clearances
35
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1154-2015Class IINAMIC Convenience Kit, 3 VALVE KIT CARDIOVASCULAR PROCEDURE KIT, UPN H749600403131, REF/Catalog No. January 9, 2015
Z-1173-2015Class IINAMIC Convenience Kit, DYE CATH LAB KIT, UPN H749601367131, REF/Catalog No. 60136713, STERILE, Rx ONJanuary 9, 2015
Z-1153-2015Class IINAMIC Convenience Kit, UPN H749600329421, REF/Catalog No. 60032942, STERILE, Rx ONLY --- For single January 9, 2015
Z-1155-2015Class IINAMIC Convenience Kit, LEFT HEART KIT, UPN H749600407061, REF/Catalog No. 60040706, STERILE, Rx ONLYJanuary 9, 2015
Z-1198-2015Class IINAMIC Convenience Kit, LEFT HEART KIT, UPN H965601017731, REF/Catalog No. 60101773, STERILE, Rx ONLYJanuary 9, 2015
Z-1148-2015Class IINAMIC Convenience Kit, LEFT HEART KIT, UPN H7496001001111, REF/Catalog No. 600100111, STERILE, Rx ONJanuary 9, 2015
Z-1171-2015Class IINAMIC Convenience Kit, UPN H7496013148131, REF/Catalog No. 601314813, STERILE, Rx ONLY --- For singlJanuary 9, 2015
Z-1165-2015Class IINAMIC Convenience Kit, LEFT/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog No. 600801020, STERILE,January 9, 2015
Z-1167-2015Class IINAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601014911, REF/Catalog No. 60101491, STERILE, Rx ONLY January 9, 2015
Z-1202-2015Class IINAMIC Convenience Kit, UPN H965601931651, REF/Catalog No. 60193165, STERILE, Rx ONLY --- For single January 9, 2015
Z-1192-2015Class IINAMIC Convenience Kit, LEFT HEART KIT, UPN H965600125911, REF/Catalog No. 60012591, STERILE, Rx ONLYJanuary 9, 2015
Z-1189-2015Class IINAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, Rx ONLY --- For single January 9, 2015
Z-1194-2015Class IINAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog No. 600302811, STERILJanuary 9, 2015
Z-1204-2015Class IINAMIC Convenience Kit, UPN H965607011741, REF/Catalog No. 60701174, STERILE, Rx ONLY --- For single January 9, 2015
Z-1170-2015Class IINAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, STERILE, Rx ONLY --- For single January 9, 2015
Z-1199-2015Class IINAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, STERILE, Rx ONLY --- For single January 9, 2015
Z-1164-2015Class IINAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, STERILE, Rx ONLY --January 9, 2015
Z-1195-2015Class IINAMIC Convenience Kit, UPN H965600338021, REF/Catalog No. 60033802, STERILE, Rx ONLY ---For single uJanuary 9, 2015
Z-1152-2015Class IINAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 60030935, STERILE, Rx ONLYJanuary 9, 2015
Z-1158-2015Class IINAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 600500113, STERILE, Rx ONJanuary 9, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K163452PICC Maximal Barrier Nursing KitFebruary 3, 2017
K161866BioFlo Midline CatheterSeptember 8, 2016
K151239NMI DUAL PORT IIJune 6, 2016
K153228NMI Port, NMI Port IIDecember 4, 2015
K152409Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCSeptember 24, 2015
K152069Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus BelSeptember 24, 2015
K150407BioFlo Midline CatheterMay 15, 2015
K150527Xcela Power Injectable PICCMarch 31, 2015
K150448NMI PICC III and NMI PICC IVMarch 19, 2015
K142616PICC Maximal Barrier Nursing KitOctober 14, 2014
K140194NAMIC RCS SYRINGEApril 14, 2014
K140266NMI PICC IVMarch 5, 2014
K131260NMI DIALYSIS CATHETERFebruary 14, 2014
K133264NMI PICC IIINovember 20, 2013
K132713NMI COAXIAL MICROINTRODUCER SETSeptember 27, 2013
K131694NMI PORT II CATHETERAugust 8, 2013
K131942NMI PICC III CATHETER, NMI HPICC III CATHETERJuly 31, 2013
K131038NMI PICC MAXIMAL BARRIER NURSING KITSMay 9, 2013
K122767NMI PORTApril 30, 2013
K123445NMI COAXIAL MICROINTRODUCER SETApril 1, 2013