Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K915238
Device Name TRAC-WRIGHT TRAC 10 CATHETER
Applicant
Dow Corning Wright
14320 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact ERIN BURLESON
Correspondent
Dow Corning Wright
14320 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact ERIN BURLESON
Regulation Number870.4875
Classification Product Code
MCW  
Date Received11/21/1991
Decision Date 02/19/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-