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 K182420
Device Name ASAHI Corsair Pro XS
Applicant
Asahi Intecc Co., Ltd.
3-100 Akatsuki-cho
Seto,  JP 489-0071
Applicant Contact Yasuyuki Kawahara
Correspondent
Cardiomed Device Consultants, LLC
3168 Braverton Street, Suite 200
Edgewater,  MD  21037
Correspondent Contact Candace Cederman
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/05/2018
Decision Date 12/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-