510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K241562Substantially Equivalent

OutFlo Aortic Valve Dilatation Balloon Catheter

Disa Medinotec (Pty) Ltd, Johannesburg, ZA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K241562 is the FDA 510(k) clearance record for OutFlo Aortic Valve Dilatation Balloon Catheter, a class II device, cleared for Disa Medinotec on under FDA product code OZT (Balloon Aortic Valvuloplasty). FDA's definition for product code OZT reads: "A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve". FDA records list 2 510(k) clearances for Disa Medinotec, from to . As of , FDA records show no recalls naming K241562.

Clearance record

Decision date
Received
(284 days to decision)
Product code
OZT Balloon Aortic Valvuloplasty
Regulation
21 CFR 870.1255
Device class
Class II
Review panel
Cardiovascular
Applicant
Disa Medinotec Stand 171, Northlands Business Park, Bush Telegraph St., Johannesburg, ZA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OZT

Trailing 12 months
2 clearances under product code OZT in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OZT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260