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, Percutaneous
510(k) Number K061119
Device Name ENPATH MEDICAL STEERABLE SHEATH
Applicant
Enpath Medical, Inc.
15301 Hwy. 55 W.
Minneapolis,  MN  55447
Applicant Contact JAMES JENKINS
Correspondent
Enpath Medical, Inc.
15301 Hwy. 55 W.
Minneapolis,  MN  55447
Correspondent Contact JAMES JENKINS
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/21/2006
Decision Date 05/18/2006
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
-
-