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FDA 510(k)

AIRE-CUF TRACHEOSTOMY TUBE

K-Number: K812163 · 1981-09-21

ApplicantBioana Surgical Instruments, Inc.
Decision Date1981-09-21
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIRE-CUF TRACHEOSTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Bioana Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1981-09-21 under 510(k) number K812163. 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 AIRE-CUF TRACHEOSTOMY TUBE?

AIRE-CUF TRACHEOSTOMY TUBE is a medical device that received FDA 510(k) clearance on 1981-09-21. The listed applicant is Bioana Surgical Instruments, Inc.. The 510(k) number is K812163.

When did AIRE-CUF TRACHEOSTOMY TUBE receive FDA 510(k) clearance?

AIRE-CUF TRACHEOSTOMY TUBE received FDA 510(k) clearance on 1981-09-21, under 510(k) number K812163.

Who is the listed applicant for AIRE-CUF TRACHEOSTOMY TUBE?

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

What is the FDA product code for AIRE-CUF TRACHEOSTOMY TUBE?

The FDA product code for AIRE-CUF TRACHEOSTOMY TUBE is JOH.

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Related Devices (Code: JOH)

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.

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, LLCK210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner CannulaSmiths Medical Asd, Inc.K203362TRACOE varioTracoe Medical GmbHK193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidienK193133Blue 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 IncorporatedK182861Shiley 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.

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