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 K133155
Device Name HYDROPHILIC COATED GUIDEWIRE
Applicant
LAKE REGION MEDICAL
340 LAKE HAZELTINE DRIVE
CHASKA,  MN  55318
Applicant Contact TRACY MEYER
Correspondent
LAKE REGION MEDICAL
340 LAKE HAZELTINE DRIVE
CHASKA,  MN  55318
Correspondent Contact TRACY MEYER
Regulation Number870.1330
Classification Product Code
DQX  
Date Received10/17/2013
Decision Date 04/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-