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 K112452
Device Name ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
Applicant
ANGIODYNAMICS, INC.
14 PLAZA DRIVE
LATHAM,  NY  12110
Applicant Contact TERI JUCKETT
Correspondent
ANGIODYNAMICS, INC.
14 PLAZA DRIVE
LATHAM,  NY  12110
Correspondent Contact TERI JUCKETT
Regulation Number870.1200
Classification Product Code
DQO  
Date Received08/25/2011
Decision Date 03/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-