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 K971504
Device Name HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER
Applicant
J-Lloyd Medical, Inc.
415 Commerce Lane, Suite 7
West Berlin,  NJ  08091
Applicant Contact JAMES L SKAGGS
Correspondent
J-Lloyd Medical, Inc.
415 Commerce Lane, Suite 7
West Berlin,  NJ  08091
Correspondent Contact JAMES L SKAGGS
Regulation Number870.1220
Classification Product Code
DRF  
Date Received04/25/1997
Decision Date 04/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-