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 Mechanical Thrombolysis Catheter
510(k) Number K950907
Device Name PULSE*SPRAY INFUSION SYSTEM
Applicant
Angiodynamics, Div. E-Z-Em, Inc.
266 Queensbury Ave.
Queensbury,  NY  12804
Applicant Contact BRIAN KUNST
Correspondent
Angiodynamics, Div. E-Z-Em, Inc.
266 Queensbury Ave.
Queensbury,  NY  12804
Correspondent Contact BRIAN KUNST
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received02/13/1995
Decision Date 05/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-