510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153069Substantially Equivalent

Edwards Balloon Catheter

Edwards Lifesciences LLC, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153069 is the FDA 510(k) clearance record for Edwards Balloon Catheter, a class II device, cleared for Edwards Lifesciences on under FDA product code OMZ (Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter). FDA's definition for product code OMZ reads: "Catheter is used for Percutaneous Transluminal or balloon Valvuloplasty (PTV) of the pulmonary (pulmonic) valve. Used on patients with isolated pulmonary stenosis and also on patients with valvular pulmonary stenosis with other minor...". FDA records list 165 510(k) clearances for Edwards Lifesciences, from to . As of , FDA records show no recalls naming K153069.

Clearance record

Decision date
Received
(77 days to decision)
Product code
OMZ Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Edwards Lifesciences 1 Edwards Way, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMZ

Trailing 12 months

FDA records hold no clearances under product code OMZ in the trailing twelve months.

FDA records show no clearances under product code OMZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OMZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260