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, Percutaneous
510(k) Number K151082
Device Name MicroCross Catheter
Applicant
Roxwood Medical, Inc.
400 Seaport Ct, Suite 103
Redwood City,  CA  94063
Applicant Contact GRACE LI
Correspondent
Roxwood Medical, Inc.
400 Seaport Ct, Suite 103
Redwood City,  CA  94063
Correspondent Contact GRACE LI
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/22/2015
Decision Date 06/07/2015
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
-
-