FDA 510(k)

Portex Blue Line Ultra Paediatric Tracheosomy Tube

Numéro K : K170720 · 2017-12-07

Date de décision2017-12-07

Code produitJOH

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Autres dossiers indiquant Smiths Medical Asd, Inc. en tant que demandeur

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

Voir tous les 16 dispositifs →

Dispositifs connexes (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

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.