Decision Date2019-03-22
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Shiley Neonatal/Pediatric Tracheostomy Tube is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K182861. 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 Shiley Neonatal/Pediatric Tracheostomy Tube?
Shiley Neonatal/Pediatric Tracheostomy Tube is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Covidien. The 510(k) number is K182861.
When did Shiley Neonatal/Pediatric Tracheostomy Tube receive FDA 510(k) clearance?
Shiley Neonatal/Pediatric Tracheostomy Tube received FDA 510(k) clearance on 2019-03-22, under 510(k) number K182861.
Who is the listed applicant for Shiley Neonatal/Pediatric Tracheostomy Tube?
The FDA 510(k) record lists Covidien as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Shiley Neonatal/Pediatric Tracheostomy Tube?
The FDA product code for Shiley Neonatal/Pediatric Tracheostomy Tube is JOH.
Other records listing Covidien 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.
View all 119 devices →
Related Devices (Code: JOH)
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.
K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLTCovidien, LLCK210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner CannulaSmiths Medical Asd, Inc.K203362TRACOE varioTracoe Medical GmbHK193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidienK193133Blue 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 IncorporatedK173912BLUperc 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.
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.