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 Permanent Pacemaker Electrode
510(k) Number K872126
Device Name MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
Applicant
Intermedics, Inc.
P.O. Box 617
Freeport,  TX  77541 -0617
Applicant Contact LISA S JONES
Correspondent
Intermedics, Inc.
P.O. Box 617
Freeport,  TX  77541 -0617
Correspondent Contact LISA S JONES
Regulation Number870.3680
Classification Product Code
DTB  
Date Received06/02/1987
Decision Date 03/22/1988
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
-
-