FDA 510(k)

VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE

K-Number: K974259 · 1998-12-01

ApplicantEdwards Lifesciences Research Medical

Decision Date1998-12-01

Product CodeDWF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences Research Medical. It received FDA 510(k) clearance on 1998-12-01 under 510(k) number K974259. 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 VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE?

VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE is a medical device that received FDA 510(k) clearance on 1998-12-01. The listed applicant is Edwards Lifesciences Research Medical. The 510(k) number is K974259.

When did VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE receive FDA 510(k) clearance?

VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE received FDA 510(k) clearance on 1998-12-01, under 510(k) number K974259.

Who is the listed applicant for VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE?

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

What is the FDA product code for VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE?

The FDA product code for VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE is DWF.

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Other records listing Edwards Lifesciences Research Medical as applicant

K07355918 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II K062429MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH K990396T-ANASTAFLO K991170RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 K983791PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA

Related Devices (Code: DWF)

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors K253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.

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.