Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Bio-Medicus Adult Cannulae Kit

K-Number: K180456 · 2018-03-22

ApplicantMedtronic, Inc.
Decision Date2018-03-22
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bio-Medicus Adult Cannulae Kit is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2018-03-22 under approval number K180456. 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 Adult Cannulae Kit?

Bio-Medicus Adult Cannulae Kit is a medical device that received FDA 510(k) clearance on 2018-03-22. It is manufactured by Medtronic, Inc.. The 510(k) number is K180456.

When was Bio-Medicus Adult Cannulae Kit approved by the FDA?

Bio-Medicus Adult Cannulae Kit received FDA 510(k) clearance on 2018-03-22, under approval number K180456.

What company makes Bio-Medicus Adult Cannulae Kit?

Bio-Medicus Adult Cannulae Kit is manufactured by Medtronic, Inc..

What is the FDA product code for Bio-Medicus Adult Cannulae Kit?

The FDA product code for Bio-Medicus Adult Cannulae Kit is DWF.

Other Devices by Medtronic, Inc.

K162896Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface K162892Achieve Advance Mapping Catheter K162054Medtronic Temporary External Pacemaker 53401 K162550Medtronic Model 5392 External Pulse Generator (EPG) K162016Affinity NT Oxygenator with Cortiva BioActive Surface K160983Kyphon HV-R Bone Cement

View all 137 devices →

Related Devices (Code: DWF)

K162214Protek Solo 24 Fr Venous Cannula SetCardiacassist, Inc. K160257PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc. K153598Medtronic Bio-Medicus Adult Cannula KitMedtronic, Inc. K171979Tubing PackMedtronic, Inc. K170488Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 FrSurge Cardiovascular K162215Aortic Arch Cannulae, Optiflow Aortic Arch CannulaeSorin Group Italia S.R.L.

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.

↑