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 K953185
Device Name PLATINUM SERIES EP DIAGNOSTIC CATHETERS
Applicant
Medtronic Cardiorhythm
130 Rio Robles
San Jose,  CA  95134
Applicant Contact KEITH V ROHRBACH
Correspondent
Medtronic Cardiorhythm
130 Rio Robles
San Jose,  CA  95134
Correspondent Contact KEITH V ROHRBACH
Regulation Number870.1220
Classification Product Code
DRF  
Date Received07/10/1995
Decision Date 04/15/1996
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
-
-