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)

Weinmann Tracheostomy Exchange Set

K-Number: K180034 · 2018-05-07

ApplicantCook Incorporated
Decision Date2018-05-07
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Weinmann Tracheostomy Exchange Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-05-07 under approval number K180034. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Weinmann Tracheostomy Exchange Set?

Weinmann Tracheostomy Exchange Set is a medical device that received FDA 510(k) clearance on 2018-05-07. It is manufactured by Cook Incorporated. The 510(k) number is K180034.

When was Weinmann Tracheostomy Exchange Set approved by the FDA?

Weinmann Tracheostomy Exchange Set received FDA 510(k) clearance on 2018-05-07, under approval number K180034.

What company makes Weinmann Tracheostomy Exchange Set?

Weinmann Tracheostomy Exchange Set is manufactured by Cook Incorporated.

What is the FDA product code for Weinmann Tracheostomy Exchange Set?

The FDA product code for Weinmann Tracheostomy Exchange Set is JOH.

Other Devices by Cook Incorporated

K160884CXI Support Catheter K161822Torcon NB Advantage Catheters K161496Turbo-Flo PICC Sets K160217uVue HSG/SHG Catheter K161002Aprima Smartesis Centesis Pump K153761Emergency Transtracheal Airway Catheter

View all 147 devices →

Related Devices (Code: JOH)

K151404ProTrach DualcareAtos Medical AB K170720Portex Blue Line Ultra Paediatric Tracheosomy TubeSmiths Medical Asd, Inc. K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tubeSmiths Medical Asd, Inc. K172720TRACOE silcosoft Tracheostomy TubeTracoe Medical GmbH K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange SetCook Incorporated K182861Shiley Neonatal/Pediatric Tracheostomy TubeCovidien

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.

↑