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FDA 510(k)

CENTRIMAG RETURN CANNULA KIT

K-Number: K110980 · 2011-06-20

ApplicantLevitronix, LLC
Decision Date2011-06-20
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CENTRIMAG RETURN CANNULA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Levitronix, LLC. It received FDA 510(k) clearance on 2011-06-20 under 510(k) number K110980. 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 CENTRIMAG RETURN CANNULA KIT?

CENTRIMAG RETURN CANNULA KIT is a medical device that received FDA 510(k) clearance on 2011-06-20. The listed applicant is Levitronix, LLC. The 510(k) number is K110980.

When did CENTRIMAG RETURN CANNULA KIT receive FDA 510(k) clearance?

CENTRIMAG RETURN CANNULA KIT received FDA 510(k) clearance on 2011-06-20, under 510(k) number K110980.

Who is the listed applicant for CENTRIMAG RETURN CANNULA KIT?

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

What is the FDA product code for CENTRIMAG RETURN CANNULA KIT?

The FDA product code for CENTRIMAG RETURN CANNULA KIT is DWF.

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Other records listing Levitronix, LLC 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.

K110983CENTRIMAG DRAINAGE CANNULA KITK102129LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITORK093832LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLESK090051LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052K090004LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLESK083340LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE

View all 11 devices →

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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