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FDA 510(k)

SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER

K-Number: K910429 · 1991-07-11

ApplicantBaxter Healthcare Corp
Decision Date1991-07-11
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER 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 1991-07-11 under 510(k) number K910429. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER?

SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER is a medical device that received FDA 510(k) clearance on 1991-07-11. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K910429.

When did SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER receive FDA 510(k) clearance?

SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER received FDA 510(k) clearance on 1991-07-11, under 510(k) number K910429.

Who is the listed applicant for SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER?

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 FLOW DIRECTED PRESSURE TD CATHETER?

The FDA product code for SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER is DXO.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: DXO)

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.

K251367OptoMonitor 3Opsens, Inc.K241418OptoMonitor 3Opsens, Inc.K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc.K222216TruWave Disposable Pressure TransducerEdwards Lifesciences, LLCK202943OptoMonitor 3Opsens, Inc.K193620OptoMonitor 3Opsens, 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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