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 Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K183649
Device Name Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable
Applicant
Baylis Medical Company Inc.
2580 Matheson Blvd. E
Mississauga,  CA L4W 4J1
Applicant Contact Meghal Khakhar
Correspondent
Baylis Medical Company Inc.
2580 Matheson Blvd. E
Mississauga,  CA L4W 4J1
Correspondent Contact Meghal Khakhar
Regulation Number870.1220
Classification Product Code
DRF  
Date Received12/26/2018
Decision Date 06/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-