FDA 510(k)

Portex Blue Line Ultra Paediatric Tracheosomy Tube

K-Number: K170720 · 2017-12-07

Decision Date2017-12-07

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Portex Blue Line Ultra Paediatric Tracheosomy Tube is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2017-12-07 under 510(k) number K170720. 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 Portex Blue Line Ultra Paediatric Tracheosomy Tube?

Portex Blue Line Ultra Paediatric Tracheosomy Tube is a medical device that received FDA 510(k) clearance on 2017-12-07. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K170720.

When did Portex Blue Line Ultra Paediatric Tracheosomy Tube receive FDA 510(k) clearance?

Portex Blue Line Ultra Paediatric Tracheosomy Tube received FDA 510(k) clearance on 2017-12-07, under 510(k) number K170720.

Who is the listed applicant for Portex Blue Line Ultra Paediatric Tracheosomy Tube?

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

What is the FDA product code for Portex Blue Line Ultra Paediatric Tracheosomy Tube?

The FDA product code for Portex Blue Line Ultra Paediatric Tracheosomy Tube is JOH.

Other records listing Smiths Medical Asd, Inc. 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.

K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula K211634Hypodermic Needle-Pro EDGE Safety Device K192375Intellifuse Administration and Intellifuse Blood Administration Sets K181699Level 1 Convective Warmer K172800Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors

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Related Devices (Code: JOH)

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, LLC K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner CannulaSmiths Medical Asd, Inc.K203362TRACOE varioTracoe Medical GmbH K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien 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.