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, Intravascular, Diagnostic
510(k) Number K912477
Device Name ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION
Applicant
Interventional Therapeutics Corp.
385 Oyster Pt. Blvd., Suite #6
South San Francisco,  CA  94080
Applicant Contact LUANNE TERMEER
Correspondent
Interventional Therapeutics Corp.
385 Oyster Pt. Blvd., Suite #6
South San Francisco,  CA  94080
Correspondent Contact LUANNE TERMEER
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/04/1991
Decision Date 11/05/1991
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
-
-