FDA 510(k) Applications Submitted by Steve Chartier

FDA 510(k) Number Submission Date Device Name Applicant
K000051 01/07/2000 ACTICOAT FOAM DRESSING WESTAIM BIOMEDICAL, INC.
K010447 02/13/2001 MODIFICATION TO ACTICOAT FOAM DRESSING WESTAIM BIOMEDICAL, INC.
K130719 03/18/2013 TVC IMAGING SYSTEM, TVC INSIGHT CATHETER Infraredx, Inc.
K001519 05/16/2000 ACTICOAT 7 DRESSING WESTAIM BIOMEDICAL, INC.
K002466 08/11/2000 ACTICOAT COMPOSITE DRESSING WESTAIM BIOMEDICAL, INC.
K002896 09/18/2000 ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING THE WESTAIM CORP.
K173008 09/27/2017 SCS 17-01 Anika Therapeutics, Inc.
K141682 06/23/2014 TVC IMAGING SYSTEM, TVC INSIGHT CATHETER Infraredx, Inc.
K123108 10/03/2012 TVC IMAGING SYSTEM MODEL NIRS-MC7-70 Infraredx, Inc.
K072932 10/16/2007 INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 Infraredx, Inc.
K133897 12/20/2013 TVC IMAGING SYSTEM, TVC INSIGHT CATHETER Infraredx, Inc.
K063805 12/22/2006 SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901 NUCRYST PHARMACEUTICALS, INC.
K093993 12/24/2009 LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 Infraredx, Inc.


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