Shiley Adult Flexible Evac Tracheostomy Tube With TaperGuard Cuff

Tube Tracheostomy And Tube Cuff

Covidien

The following data is part of a premarket notification filed by Covidien with the FDA for Shiley Adult Flexible Evac Tracheostomy Tube With Taperguard Cuff.

Pre-market Notification Details

Device IDK193077
510k NumberK193077
Device Name:Shiley Adult Flexible Evac Tracheostomy Tube With TaperGuard Cuff
ClassificationTube Tracheostomy And Tube Cuff
Applicant Covidien 6135 Gunbarrel Ave Boulder,  CO  80301
ContactStacy Barton
CorrespondentStacy Barton
Covidien 6135 Gunbarrel Ave Boulder,  CO  80301
Product CodeJOH  
CFR Regulation Number868.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-05
Decision Date2020-06-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521726212 K193077 000
20884521726250 K193077 000
20884521726229 K193077 000
20884521726205 K193077 000
20884521726441 K193077 000
20884521726427 K193077 000
20884521726403 K193077 000
20884521726397 K193077 000
20884521726311 K193077 000
20884521726267 K193077 000
20884521726274 K193077 000
20884521726281 K193077 000
20884521726199 K193077 000
20884521726243 K193077 000
20884521726434 K193077 000
20884521726304 K193077 000
20884521726236 K193077 000
20884521726458 K193077 000
20884521726410 K193077 000
20884521726328 K193077 000
20884521726298 K193077 000

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