510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K172423Substantially Equivalent

PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)

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

K172423 is the FDA 510(k) clearance record for PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter), a class II device, cleared for Edwards Lifescience, LLC on under FDA product code DQE (Catheter, Oximeter, Fiber-Optic). FDA records list one 510(k) clearance for Edwards Lifescience, LLC. As of , FDA records show one recall naming K172423.

Clearance record

Decision date
Received
(194 days to decision)
Product code
DQE Catheter, Oximeter, Fiber-Optic
Regulation
21 CFR 870.1230
Device class
Class II
Review panel
Cardiovascular
Applicant
Edwards Lifescience, 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