510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053609Substantially Equivalent

Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac Output/oximetry Monitor

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

K053609 is the FDA 510(k) clearance record for PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, a class II device, cleared for Edwards Lifesciences, LLC on under FDA product code DQE (Catheter, Oximeter, Fiber-Optic). FDA records list 165 510(k) clearances for Edwards Lifesciences, LLC, from to . As of , FDA records show 6 recalls naming K053609.

Clearance record

Decision date
Received
(63 days to decision)
Product code
DQE Catheter, Oximeter, Fiber-Optic
Regulation
21 CFR 870.1230
Device class
Class II
Review panel
Cardiovascular
Applicant
Edwards Lifesciences, LLC One Edwards Way, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQE

Trailing 12 months

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

FDA records show no clearances under product code DQE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DQE, 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