FDA 510(k)

SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER

K-Number: K924452 · 1993-10-29

Decision Date1993-10-29

Product CodeDYG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SWAN-GANZ CCO/SVO2 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 1993-10-29 under 510(k) number K924452. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER?

SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER is a medical device that received FDA 510(k) clearance on 1993-10-29. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K924452.

When did SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER receive FDA 510(k) clearance?

SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER received FDA 510(k) clearance on 1993-10-29, under 510(k) number K924452.

Who is the listed applicant for SWAN-GANZ CCO/SVO2 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 CCO/SVO2 THERMODILUTION CATHETER?

The FDA product code for SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER is DYG.

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Related Devices (Code: DYG)

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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.