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FDA 510(k)

VOYAGER QUAD CANNULA

K-Number: K983270 · 1999-07-28

ApplicantCardiothoracic Systems, Inc.
Decision Date1999-07-28
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VOYAGER QUAD CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Cardiothoracic Systems, Inc.. It received FDA 510(k) clearance on 1999-07-28 under 510(k) number K983270. 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 VOYAGER QUAD CANNULA?

VOYAGER QUAD CANNULA is a medical device that received FDA 510(k) clearance on 1999-07-28. The listed applicant is Cardiothoracic Systems, Inc.. The 510(k) number is K983270.

When did VOYAGER QUAD CANNULA receive FDA 510(k) clearance?

VOYAGER QUAD CANNULA received FDA 510(k) clearance on 1999-07-28, under 510(k) number K983270.

Who is the listed applicant for VOYAGER QUAD CANNULA?

The FDA 510(k) record lists Cardiothoracic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VOYAGER QUAD CANNULA?

The FDA product code for VOYAGER QUAD CANNULA is DWF.

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Other records listing Cardiothoracic Systems, Inc. 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.

K010117GUIDANT AXIUS CORONARY SHUNTK982419HEART-LIFT BALLOON POSITIONERK983135BLOWER/MISTERK963965CTS MIDCAB STITCHERK970638CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNTK963503CTS MIDCAB CORONARY SHUNT

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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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