FDA 510(k)

SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF

K-Number: K930895 · 1993-07-02

Decision Date1993-07-02

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Medical Tpi, Inc.. It received FDA 510(k) clearance on 1993-07-02 under 510(k) number K930895. 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 FENESTRATED REUSABLE INNER CANNULA, MODIF?

SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF is a medical device that received FDA 510(k) clearance on 1993-07-02. The listed applicant is Mallinckrodt Medical Tpi, Inc.. The 510(k) number is K930895.

When did SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF receive FDA 510(k) clearance?

SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF received FDA 510(k) clearance on 1993-07-02, under 510(k) number K930895.

Who is the listed applicant for SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF?

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

What is the FDA product code for SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF?

The FDA product code for SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF is JOH.

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Other records listing Mallinckrodt Medical Tpi, Inc. as applicant

K945407SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT K945406SSV PHONATE(TM) SHILEY SPEAKING VALVE K936224REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.