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 K024126
Device Name CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
Applicant
ABBOTT LABORATORIES
200 ABBOTT PARK RD.
D-389, BLDG J-45
ABBOTT PARK,  IL  60064 -3500
Applicant Contact NICOHL R WILDING
Correspondent
ABBOTT LABORATORIES
200 ABBOTT PARK RD.
D-389, BLDG J-45
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact NICOHL R WILDING
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/16/2002
Decision Date 01/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
-
-