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, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K891908
Device Name BARD(R) TIP DEFLECTING ELECTRODE CATHETER
Applicant
C.R. Bard, Inc.
5 Federal St.
P.O. Box 5069
Billerica,  MA  01822
Applicant Contact ERNEST MANFREDO
Correspondent
C.R. Bard, Inc.
5 Federal St.
P.O. Box 5069
Billerica,  MA  01822
Correspondent Contact ERNEST MANFREDO
Regulation Number870.1220
Classification Product Code
DRF  
Date Received03/27/1989
Decision Date 06/05/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-