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FDA 510(k)

SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER

K-Number: K905458 · 1991-02-07

ApplicantBaxter Healthcare Corp
Decision Date1991-02-07
Product CodeDQE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER 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 1991-02-07 under 510(k) number K905458. 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 SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER?

SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER is a medical device that received FDA 510(k) clearance on 1991-02-07. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K905458.

When did SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER receive FDA 510(k) clearance?

SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER received FDA 510(k) clearance on 1991-02-07, under 510(k) number K905458.

Who is the listed applicant for SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER?

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 SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER?

The FDA product code for SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER is DQE.

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Related Devices (Code: DQE)

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.

K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)Edwards Lifescience, LLCK160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLCK110167PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)Edwards Lifesciences, LLCK091268HOSPIRA 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.

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