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 K100769
Device Name PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054
Applicant
PENUMBRA, INC.
1351 HARBOR BAY PKWY.
ALAMEDA,  CA  94502
Applicant Contact MICHAELA MAHL
Correspondent
PENUMBRA, INC.
1351 HARBOR BAY PKWY.
ALAMEDA,  CA  94502
Correspondent Contact MICHAELA MAHL
Regulation Number870.1250
Classification Product Code
NRY  
Date Received03/18/2010
Decision Date 05/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-