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, Flow Directed
510(k) Number K901287
Device Name INTHERM TEMPORARY OCCLUSION CATHETER
Applicant
Interventional Therapeutics Corp.
2665 Marine Way
Mountain View,  CA  94043
Applicant Contact COLIN J NICHOLS
Correspondent
Interventional Therapeutics Corp.
2665 Marine Way
Mountain View,  CA  94043
Correspondent Contact COLIN J NICHOLS
Regulation Number870.1240
Classification Product Code
DYG  
Date Received03/20/1990
Decision Date 02/20/1991
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
-
-