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FDA 510(k)

AXILLARY ACCESS ARTERIAL CANNULA

K-Number: K002578 · 2002-04-11

ApplicantEdwards Lifesciences, LLC
Decision Date2002-04-11
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AXILLARY ACCESS ARTERIAL CANNULA 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 2002-04-11 under 510(k) number K002578. 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 AXILLARY ACCESS ARTERIAL CANNULA?

AXILLARY ACCESS ARTERIAL CANNULA is a medical device that received FDA 510(k) clearance on 2002-04-11. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K002578.

When did AXILLARY ACCESS ARTERIAL CANNULA receive FDA 510(k) clearance?

AXILLARY ACCESS ARTERIAL CANNULA received FDA 510(k) clearance on 2002-04-11, under 510(k) number K002578.

Who is the listed applicant for AXILLARY ACCESS ARTERIAL CANNULA?

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 AXILLARY ACCESS ARTERIAL CANNULA?

The FDA product code for AXILLARY ACCESS ARTERIAL CANNULA 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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.

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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