• 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 K192782
Device Name ASAHI CROSSWALK Peripheral Support Catheter
Asahi Intecc Co., Ltd.
3-100 Akatsuki-cho
seto,  JP 489-0071
Applicant Contact yasuyuki kawuhara
Asahi Intecc USA, Inc.
3002 Dow Avenue, Suite 212
tustin,  CA  92780
Correspondent Contact cynthia valenzuela
Regulation Number870.1250
Classification Product Code
Date Received09/30/2019
Decision Date 11/29/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No