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 Reprocessed Intravascular Ultrasound Catheter
510(k) Number K033436
Device Name REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER
Applicant
Alliance Medical Corp.
10232 S. 51st St.
Phoenix,  AZ  85044
Applicant Contact MOIRA BARTON
Correspondent
Alliance Medical Corp.
10232 S. 51st St.
Phoenix,  AZ  85044
Correspondent Contact MOIRA BARTON
Regulation Number870.1200
Classification Product Code
OWQ  
Date Received10/28/2003
Decision Date 03/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-