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 Wire, Guide, Catheter
510(k) Number K202543
Device Name OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
Applicant
Volcano Corporation
3721 Valley Centre Dr., Suite 500
San Diego,  CA  92130
Applicant Contact Patrick Juarez
Correspondent
Volcano Corporation
3721 Valley Centre Dr., Suite 500
San Diego,  CA  92130
Correspondent Contact Patrick Juarez
Regulation Number870.1330
Classification Product Code
DQX  
Subsequent Product Code
DXO  
Date Received09/02/2020
Decision Date 09/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-