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, therapeutic, short-term less than 30 days
510(k) Number K971991
Device Name GESCO PER-Q-CATH MIDLINE CATHETERS
Applicant
BARD ACCESS SYSTEMS, INC.
5425 WEST AMELIA EARNHART DR.
SALT LAKE CITY,  UT  84116
Applicant Contact JANE ANN MARTIN
Correspondent
BARD ACCESS SYSTEMS, INC.
5425 WEST AMELIA EARNHART DR.
SALT LAKE CITY,  UT  84116
Correspondent Contact JANE ANN MARTIN
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/09/1997
Decision Date 11/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-