• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name surgical device, for ablation of cardiac tissue
510(k) Number K113475
Device Name ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM
Original Applicant
ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH
2603 camino ramon
suite 100
san ramon,  CA  94583
Original Contact tamer ibrahim
Regulation Number878.4400
Classification Product Code
OCL  
Date Received11/22/2011
Decision Date 03/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-