← Back to catalogue

Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP …

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223130

by Covidien

Identifiers

510(k) Number
K223130 FDA 510(k)
FDA Product Code
BTR FDA 510(k)
Models / Variants
86125 FDA 510(k)
86130 FDA 510(k)
86135 FDA 510(k)
86140 FDA 510(k)
86145 FDA 510(k)
86150 FDA 510(k)
86155 FDA 510(k)
86160 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5730 FDA 510(k)
Regulation Number
868.5730 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP … by Covidien — Class II — FDA_510K — listed in FDA 510(k) — 8 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Covidien

Sources (1)

  • FDA 510(k) K223130 24 fields · synced Jun 18, 2026