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FDA 510(k)

SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER

K-Number: K924661 · 1993-04-08

ApplicantBaxter Healthcare Corp
Decision Date1993-04-08
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SWAN-GANZ INTELLICATH CCO THERMODILUTION 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 1993-04-08 under 510(k) number K924661. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER?

SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER is a medical device that received FDA 510(k) clearance on 1993-04-08. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K924661.

When did SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER receive FDA 510(k) clearance?

SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER received FDA 510(k) clearance on 1993-04-08, under 510(k) number K924661.

Who is the listed applicant for SWAN-GANZ INTELLICATH CCO THERMODILUTION 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 INTELLICATH CCO THERMODILUTION CATHETER?

The FDA product code for SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER is KRA.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: KRA)

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.

K253509TriSalus TriNav Advance Infusion SystemTrisalus Life SciencesK254051Extroducer Infusion Catheter SystemSmartWise Sweden ABK261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech Limited

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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