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FDA 510(k)

Tubing Pack

K-Number: K171308 · 2017-06-02

ApplicantMedtronic, Inc.
Decision Date2017-06-02
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tubing Pack is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K171308. 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 Tubing Pack?

Tubing Pack is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Medtronic, Inc.. The 510(k) number is K171308.

When did Tubing Pack receive FDA 510(k) clearance?

Tubing Pack received FDA 510(k) clearance on 2017-06-02, under 510(k) number K171308.

Who is the listed applicant for Tubing Pack?

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

What is the FDA product code for Tubing Pack?

The FDA product code for Tubing Pack 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.

NCT00271180Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy ProductsRECRUITINGNCT07005232Lead Evaluation for Defibrillation and Reliability Post Approval StudyENROLLING_BY_INVITATION

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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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