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FDA 510(k)

SWAN-GANZ FLOW-DIRECTED CATHETER

K-Number: K791183 · 1979-07-12

ApplicantEdwards Lifesciences, LLC
Decision Date1979-07-12
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SWAN-GANZ FLOW-DIRECTED CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 1979-07-12 under 510(k) number K791183. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWAN-GANZ FLOW-DIRECTED CATHETER?

SWAN-GANZ FLOW-DIRECTED CATHETER is a medical device that received FDA 510(k) clearance on 1979-07-12. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K791183.

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

SWAN-GANZ FLOW-DIRECTED CATHETER received FDA 510(k) clearance on 1979-07-12, under 510(k) number K791183.

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

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SWAN-GANZ FLOW-DIRECTED CATHETER?

The FDA product code for SWAN-GANZ FLOW-DIRECTED CATHETER is LDF.

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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.

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