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 K941978
Device Name HIGH PRESSURE TUBING
Applicant
ABBOTT LABORATORIES
D-389, AP-30
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -3537
Applicant Contact FREDERIK A GUSTAFSON
Correspondent
ABBOTT LABORATORIES
D-389, AP-30
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -3537
Correspondent Contact FREDERIK A GUSTAFSON
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/14/1994
Decision Date 12/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-