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FDA 510(k)

EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE

K-Number: K092509 · 2009-10-08

ApplicantEdwards Lifesciences, LLC
Decision Date2009-10-08
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE 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 2009-10-08 under 510(k) number K092509. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE?

EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE is a medical device that received FDA 510(k) clearance on 2009-10-08. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K092509.

When did EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE receive FDA 510(k) clearance?

EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE received FDA 510(k) clearance on 2009-10-08, under 510(k) number K092509.

Who is the listed applicant for EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE?

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 EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE?

The FDA product code for EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE is DWF.

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Related Devices (Code: DWF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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