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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name patch, pledget and intracardiac, petp, ptfe, polypropylene
510(K) Number K122105
Device Name SMI CARDIOVASCULAR PATCH
Applicant
SOLINAS MEDICAL INC
443 costa mesa terrace
sunny vale,  CA  94089
Contact james hong
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received07/17/2012
Decision Date 12/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-