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FDA 510(k)

PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA

K-Number: K983791 · 1999-06-11

ApplicantEdwards Lifesciences Research Medical
Decision Date1999-06-11
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA 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 1999-06-11 under 510(k) number K983791. 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 PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA?

PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA is a medical device that received FDA 510(k) clearance on 1999-06-11. The listed applicant is Edwards Lifesciences Research Medical. The 510(k) number is K983791.

When did PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA receive FDA 510(k) clearance?

PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA received FDA 510(k) clearance on 1999-06-11, under 510(k) number K983791.

Who is the listed applicant for PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA?

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 PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA?

The FDA product code for PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA is DWF.

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Other records listing Edwards Lifesciences Research Medical as applicant

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.

K07355918 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA IIK062429MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESHK990396T-ANASTAFLOK991170RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014K974259VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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