FDA 510(k)

TRACHEOSTOMY TUBES TRACOE-FLEX

K-Number: K961449 · 1996-09-13

Decision Date1996-09-13

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

TRACHEOSTOMY TUBES TRACOE-FLEX is the device name listed in this FDA 510(k) record. The listed applicant is Tracoe Medical GmbH. It received FDA 510(k) clearance on 1996-09-13 under 510(k) number K961449. 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 TRACHEOSTOMY TUBES TRACOE-FLEX?

TRACHEOSTOMY TUBES TRACOE-FLEX is a medical device that received FDA 510(k) clearance on 1996-09-13. The listed applicant is Tracoe Medical GmbH. The 510(k) number is K961449.

When did TRACHEOSTOMY TUBES TRACOE-FLEX receive FDA 510(k) clearance?

TRACHEOSTOMY TUBES TRACOE-FLEX received FDA 510(k) clearance on 1996-09-13, under 510(k) number K961449.

Who is the listed applicant for TRACHEOSTOMY TUBES TRACOE-FLEX?

The FDA 510(k) record lists Tracoe Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRACHEOSTOMY TUBES TRACOE-FLEX?

The FDA product code for TRACHEOSTOMY TUBES TRACOE-FLEX is JOH.

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Other records listing Tracoe Medical GmbH as applicant

K203362TRACOE vario K172720TRACOE silcosoft Tracheostomy Tube K152778TRACOE Cuff Pressure Monitor K152865TRACOE smart Cuff Manager K051587TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 K043160TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO

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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.