OXIMETRY PROBE CATHETERS— 510(k) K901736

Name: FDA 510(k) clearance K901736
Creator: U.S. Food and Drug Administration
Published: 1990-09-11

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K901736 for OXIMETRY PROBE CATHETERS, Substantially Equivalent on 1990-09-11. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code DQE
Device class: Class 2
Regulation: 21 CFR 870.1230
Advisory panel: Cardiovascular
Date received: 1990-04-17
Decision date: 1990-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQE

view all

K172423 — PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)2018-02-20
K160645 — PreSep Oligon Oximetry Catheter2016-06-16
K140129 — PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER2014-07-02
K110167 — PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)2011-02-18
K091268 — HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS2009-09-18

More clearances from Baxter Healthcare Corp

view all

K190910 — PrisMax System Version 22019-07-25
K163530 — PrisMax Control Unit2017-05-03
K130531 — ULTRAFUSE2014-04-08
K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS2013-10-08
K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO2013-03-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.