Medical Device Manufacturer · US , Marlborough , MA

Navilyst Medical, Inc. - FDA 510(k) Cleared Devices

35 submissions · 33 cleared · Since 2009

Recent clearances: PICC Maximal Barrier Nursing Kit, BioFlo Midline Catheter, NMI DUAL PORT II

Official Website

35

Total

33

Cleared

0

Denied

FDA 510(k) Regulatory Record - Navilyst Medical, Inc. Cardiovascular ✕

7 devices

1-7 of 7

Cleared Sep 27, 2013

NMI COAXIAL MICROINTRODUCER SET

Cardiovascular · 28d

Cleared Apr 01, 2013

NMI COAXIAL MICROINTRODUCER SET

Cardiovascular · 144d

Cleared Jul 17, 2012

NMI MICROCATHETER

Cardiovascular · 14d

Cleared Jan 05, 2012

NMI 2.8 MICROCATHETER

Cardiovascular · 27d

Cleared Nov 28, 2011

NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML

Cardiovascular · 28d

Cleared Aug 19, 2011

Cardiovascular · 25d

Cleared Mar 01, 2010

Cardiovascular · 270d