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, Intravascular Occluding, Temporary
510(k) Number K143613
Device Name PaxWire Occlusion Balloon System
Applicant
Accessclosure, Inc.
5452 Besty Ross Dr.
Santa Clara,  CA  95054
Applicant Contact Kelly Jabbal
Correspondent
Accessclosure, Inc.
5452 Besty Ross Dr.
Santa Clara,  CA  95054
Correspondent Contact Kelly Jabbal
Regulation Number870.4450
Classification Product Code
MJN  
Date Received12/19/2014
Decision Date 08/14/2015
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
Recalls CDRH Recalls
-
-