Name: Predicase
Price: 199 USD

K-number	K223130
Device name	Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
Applicant	Covidien
Product code	BTR
Device class	Class II
Decision date	Aug 30, 2023
Decision	Substantially Equivalent
Regulation	868.5730

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Source

View the full FDA submission: accessdata.fda.gov

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Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)

Everything you need for a 510(k) submission. Nothing you don't.

Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)