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 introducer, catheter
510(k) Number K170997
Device Name CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
Applicant
Biosense Webster, Inc.
33 Technology Drive
Irvine,  CA  92618
Applicant Contact John Jimenez
Correspondent
Biosense Webster, Inc.
33 Technology Drive
Irvine,  CA  92618
Correspondent Contact John Jimenez
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/03/2017
Decision Date 07/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-