• 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 | Inspections
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 K122772
Device Name PENUMBRA DDC CATHETERS
Original Applicant
PENUMBRA, INC.
1351 harbor bay parkway
alameda,  CA  94502
Original Contact seth schulman
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/10/2012
Decision Date 11/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-