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 Wire, Guide, Catheter
510(k) Number K110241
Device Name ENDOLOGIX GUIDEWIRE
Applicant
Techdevice Corporation
650 Pleasant St.
Watertown,  MA  02472
Applicant Contact GARY BUNNEWITH
Correspondent
Techdevice Corporation
650 Pleasant St.
Watertown,  MA  02472
Correspondent Contact GARY BUNNEWITH
Regulation Number870.1330
Classification Product Code
DQX  
Date Received01/27/2011
Decision Date 02/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-