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Tube Tracheostomy And Tube Cuff

FDA product code JOH · 103 cleared devices

Class 2 Anesthesiology
Regulation
21 CFR 868.5800
Review panel
AN
Implant
No
Life sustaining
Yes
Third party review
Yes
GMP exempt
No
Clearance span
1976-09-13 – 2025-12-29
JOH 2025-12-29

Shiley™ 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 XLT

Applicant Covidien, LLC

K number K251313

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