• 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 electrode, pacemaker, temporary
510(k) Number K002687
Device Name ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3
Applicant
ZYNERGY CARDIOVASCULAR, INC.
298 FERNWOOD AVE.
edison,  NJ  08837 -3839
Applicant Contact jing zhang
Correspondent
ZYNERGY CARDIOVASCULAR, INC.
298 FERNWOOD AVE.
edison,  NJ  08837 -3839
Correspondent Contact jing zhang
Regulation Number870.3680
Classification Product Code
LDF  
Date Received08/29/2000
Decision Date 11/09/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-