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510(k) K220881

INOUE BALLOON A by Toray Industries, Inc. — Product Code OZT

K220881 is an FDA 510(k) premarket notification submitted by Toray Industries, Inc. for the device "INOUE BALLOON A". The FDA issued a decision of Substantially Equivalent on December 18, 2022. The device falls under product code OZT (Balloon Aortic Valvuloplasty), a Class II device regulated under 21 CFR 870.1255.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2022
Date Received
March 25, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Balloon Aortic Valvuloplasty
Device Class
Class II
Regulation Number
870.1255
Review Panel
CV
Submission Type

A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.

Other clearances for product code OZT

  • K253855 — KardiaPSI Balloon Catheter (May 6, 2026)
  • K260437 — Valvuloplasty Balloon Catheter (ValvuloPro) (March 20, 2026)
  • K241562 — OutFlo Aortic Valve Dilatation Balloon Catheter (March 11, 2025)
  • K240967 — ValvuloPro Valvuloplasty Balloon Catheter (July 31, 2024)
  • K231814 — ValvuloPro Valvuloplasty Balloon Catheter (October 12, 2023)
  • K172932 — True Flow Valvuloplasty Perfusion Catheter (December 13, 2017)
  • K152613 — True Flow Valvuloplasty Perfusion Catheter (January 19, 2016)
  • K152150 — V8 Balloon Aortic Valvuloplasty Catheter (December 18, 2015)
  • K150667 — True Dilatation Balloon Valvuloplasty Catheter (June 17, 2015)
  • K142083 — TRUE FLOW VALVULOPLASTY PERFUSION CATHETER (April 17, 2015)

FDA data resources