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FDA 510(k)

NOVAPORT ONE VASCULAR ACCESS CANNULA

K-Number: K112565 · 2011-12-06

ApplicantNovalung GmbH
Decision Date2011-12-06
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NOVAPORT ONE VASCULAR ACCESS CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Novalung GmbH. It received FDA 510(k) clearance on 2011-12-06 under 510(k) number K112565. 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 NOVAPORT ONE VASCULAR ACCESS CANNULA?

NOVAPORT ONE VASCULAR ACCESS CANNULA is a medical device that received FDA 510(k) clearance on 2011-12-06. The listed applicant is Novalung GmbH. The 510(k) number is K112565.

When did NOVAPORT ONE VASCULAR ACCESS CANNULA receive FDA 510(k) clearance?

NOVAPORT ONE VASCULAR ACCESS CANNULA received FDA 510(k) clearance on 2011-12-06, under 510(k) number K112565.

Who is the listed applicant for NOVAPORT ONE VASCULAR ACCESS CANNULA?

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

What is the FDA product code for NOVAPORT ONE VASCULAR ACCESS CANNULA?

The FDA product code for NOVAPORT ONE VASCULAR ACCESS CANNULA is DWF.

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Other records listing Novalung GmbH 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.

K072362NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG

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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