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FDA 510(k)

Bio-Medicus Life Support Catheter and Introducer

K-Number: K201100 · 2021-07-15

ApplicantMedtronic, Inc.
Decision Date2021-07-15
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bio-Medicus Life Support Catheter and Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2021-07-15 under 510(k) number K201100. 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 Bio-Medicus Life Support Catheter and Introducer?

Bio-Medicus Life Support Catheter and Introducer is a medical device that received FDA 510(k) clearance on 2021-07-15. The listed applicant is Medtronic, Inc.. The 510(k) number is K201100.

When did Bio-Medicus Life Support Catheter and Introducer receive FDA 510(k) clearance?

Bio-Medicus Life Support Catheter and Introducer received FDA 510(k) clearance on 2021-07-15, under 510(k) number K201100.

Who is the listed applicant for Bio-Medicus Life Support Catheter and Introducer?

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 Bio-Medicus Life Support Catheter and Introducer?

The FDA product code for Bio-Medicus Life Support Catheter and Introducer is DWF.

Related Clinical Trials

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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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