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, Thrombus Retriever
510(k) Number K161064
Device Name Penumbra System ACE 68 Reperfusion Catheter
Applicant
Penumbra, Inc.
One Penumbra Place
Alameda,  CA  94502
Applicant Contact Charles DeNault
Correspondent
Penumbra, Inc.
One Penumbra Place
Alameda,  CA  94502
Correspondent Contact Charles DeNault
Regulation Number870.1250
Classification Product Code
NRY  
Date Received04/15/2016
Decision Date 06/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-