FDA 510(k)

SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F

K-Number: K894168 · 1989-11-27

Decision Date1989-11-27

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F 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 1989-11-27 under 510(k) number K894168. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F?

SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F is a medical device that received FDA 510(k) clearance on 1989-11-27. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K894168.

When did SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F receive FDA 510(k) clearance?

SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F received FDA 510(k) clearance on 1989-11-27, under 510(k) number K894168.

Who is the listed applicant for SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F?

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 THERM CATH SM HEART AMC THROM 93A102H5F?

The FDA product code for SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F is DQO.

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Official Source

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