FDA 510(k)

SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)

K-Number: K910204 · 1991-04-24

Decision Date1991-04-24

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM) 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 1991-04-24 under 510(k) number K910204. 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(R) HI-SHORE(R) THERMO CATH W/AMC(TM)?

SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM) is a medical device that received FDA 510(k) clearance on 1991-04-24. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K910204.

When did SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM) receive FDA 510(k) clearance?

SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM) received FDA 510(k) clearance on 1991-04-24, under 510(k) number K910204.

Who is the listed applicant for SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)?

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) HI-SHORE(R) THERMO CATH W/AMC(TM)?

The FDA product code for SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM) 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.