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 Balloon Aortic Valvuloplasty
510(k) Number K220881
Device Name INOUE BALLOON A
Applicant
Toray Industries, Inc.
1-1, Nihombashi-Muromachi 2-Chome
Chuo-Ku,  JP 103-8666
Applicant Contact Satoshi Kakuyama
Correspondent
Toray Industries (America), Inc.
461 Fifth Ave.
9th Floor
New York,  NY  10017
Correspondent Contact Yuya Shizume
Regulation Number870.1255
Classification Product Code
OZT  
Date Received03/25/2022
Decision Date 12/18/2022
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
-
-