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510(k) K241562

OutFlo Aortic Valve Dilatation Balloon Catheter by Disa Medinotec — Product Code OZT

K241562 is an FDA 510(k) premarket notification submitted by Disa Medinotec for the device "OutFlo Aortic Valve Dilatation Balloon Catheter". The FDA issued a decision of Substantially Equivalent on March 11, 2025. The device falls under product code OZT (Balloon Aortic Valvuloplasty), a Class II device regulated under 21 CFR 870.1255. Disa Medinotec has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2025
Date Received
May 31, 2024
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 by Disa Medinotec

  • K211894 — Trachealator (November 24, 2021)

Other clearances for product code OZT

  • K253855 — KardiaPSI Balloon Catheter (May 6, 2026)
  • K260437 — Valvuloplasty Balloon Catheter (ValvuloPro) (March 20, 2026)
  • K240967 — ValvuloPro Valvuloplasty Balloon Catheter (July 31, 2024)
  • K231814 — ValvuloPro Valvuloplasty Balloon Catheter (October 12, 2023)
  • K220881 — INOUE BALLOON A (December 18, 2022)
  • 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