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FDA 510(k)

SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.

K-Number: K803058 · 1981-01-16

ApplicantAmerican Edwards Laboratories
Decision Date1981-01-16
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH. is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1981-01-16 under 510(k) number K803058. 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 MULTIPUR. CATH.?

SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH. is a medical device that received FDA 510(k) clearance on 1981-01-16. The listed applicant is American Edwards Laboratories. The 510(k) number is K803058.

When did SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH. receive FDA 510(k) clearance?

SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH. received FDA 510(k) clearance on 1981-01-16, under 510(k) number K803058.

Who is the listed applicant for SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.?

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

What is the FDA product code for SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.?

The FDA product code for SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH. 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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