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 K053491
Device Name PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F
Applicant
Penumbra, Inc.
2401 Merced St.
Suite 200
San Leandro,  CA  94577
Applicant Contact THERESA BRANDNER-ALLEN
Correspondent
Penumbra, Inc.
2401 Merced St.
Suite 200
San Leandro,  CA  94577
Correspondent Contact THERESA BRANDNER-ALLEN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/15/2005
Decision Date 04/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-