FDA 510(k)

SHILEY FENESTRATED LOW PRESS. CUFFED

K-Number: K812302 · 1981-09-08

Decision Date1981-09-08

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SHILEY FENESTRATED LOW PRESS. CUFFED is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1981-09-08 under 510(k) number K812302. 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 LOW PRESS. CUFFED?

SHILEY FENESTRATED LOW PRESS. CUFFED is a medical device that received FDA 510(k) clearance on 1981-09-08. The listed applicant is Shiley, Inc.. The 510(k) number is K812302.

When did SHILEY FENESTRATED LOW PRESS. CUFFED receive FDA 510(k) clearance?

SHILEY FENESTRATED LOW PRESS. CUFFED received FDA 510(k) clearance on 1981-09-08, under 510(k) number K812302.

Who is the listed applicant for SHILEY FENESTRATED LOW PRESS. CUFFED?

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

What is the FDA product code for SHILEY FENESTRATED LOW PRESS. CUFFED?

The FDA product code for SHILEY FENESTRATED LOW PRESS. CUFFED is JOH.

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Other records listing Shiley, Inc. as applicant

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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.