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FDA 510(k)

VORTEX CANNULA

K-Number: K091304 · 2009-07-02

ApplicantVortex Medical, Inc.
Decision Date2009-07-02
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VORTEX CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Vortex Medical, Inc.. It received FDA 510(k) clearance on 2009-07-02 under 510(k) number K091304. 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 VORTEX CANNULA?

VORTEX CANNULA is a medical device that received FDA 510(k) clearance on 2009-07-02. The listed applicant is Vortex Medical, Inc.. The 510(k) number is K091304.

When did VORTEX CANNULA receive FDA 510(k) clearance?

VORTEX CANNULA received FDA 510(k) clearance on 2009-07-02, under 510(k) number K091304.

Who is the listed applicant for VORTEX CANNULA?

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

What is the FDA product code for VORTEX CANNULA?

The FDA product code for VORTEX CANNULA is DWF.

Related Clinical Trials

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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Other records listing Vortex Medical, 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.

K092486VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT

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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