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 K141981
Device Name ASAHI FUBUKI 043 / ASAHI FUBUKI
Applicant
ASAHI INTECC CO., LTD.
5523 RESEARCH PARK DRIVE,
SUITE 205
BALTIMORE,  MD  21228
Applicant Contact CANDACE CEDERMAN
Correspondent
ASAHI INTECC CO., LTD.
5523 RESEARCH PARK DRIVE,
SUITE 205
BALTIMORE,  MD  21228
Correspondent Contact CANDACE CEDERMAN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/21/2014
Decision Date 03/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-