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 K903221
Device Name LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN
Applicant
TELECTRONICS PACING SYSTEMS, INC.
7400 SOUTH TUCSON WAY
ENGLEWOOD,  CO  80112
Applicant Contact DUANE A SCHULTZ
Correspondent
TELECTRONICS PACING SYSTEMS, INC.
7400 SOUTH TUCSON WAY
ENGLEWOOD,  CO  80112
Correspondent Contact DUANE A SCHULTZ
Regulation Number870.3680
Classification Product Code
DTB  
Date Received07/23/1990
Decision Date 11/08/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-