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 Transducer, Ultrasonic, Diagnostic
510(k) Number K912600
Device Name INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER
Applicant
Intertherapy, Inc.
1936 E. Deere Ave., Suite 120
Santa Ana,  CA  92705
Applicant Contact THOMAS P SCHROEDER
Correspondent
Intertherapy, Inc.
1936 E. Deere Ave., Suite 120
Santa Ana,  CA  92705
Correspondent Contact THOMAS P SCHROEDER
Regulation Number892.1570
Classification Product Code
ITX  
Date Received06/10/1991
Decision Date 11/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-