FDA 510(k)

EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH

K-Number: K926450 · 1993-02-22

Decision Date1993-02-22

Product CodeDQE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1993-02-22 under 510(k) number K926450. The device is classified under product code DQE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH?

EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH is a medical device that received FDA 510(k) clearance on 1993-02-22. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K926450.

When did EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH receive FDA 510(k) clearance?

EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH received FDA 510(k) clearance on 1993-02-22, under 510(k) number K926450.

Who is the listed applicant for EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH?

The FDA product code for EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH is DQE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Baxter Healthcare Corp as applicant

K190910PrisMax System Version 2 K163530PrisMax Control Unit K132734NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS K130245LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO K123874INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S K123868INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET

View all 504 devices →

Related Devices (Code: DQE)

K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)Edwards Lifescience, LLC K160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC K110167PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)Edwards Lifesciences, LLC K091268HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERSHospira, Inc.K062999OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARINHospira, Inc.K061585OPTICATH CENTRAL VENOUS OXIMETRY CATHETERHospira, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.