DeviceClearance

Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula— 510(k) K150844

Substantially Equivalent

Covidien

FDA 510(k) clearance K150844 for Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula, Substantially Equivalent on 2015-07-14. Applicant: Covidien. Device class: 2.

Clearance details

Applicant
Covidien
Product code
Code JOH
Device class
Class 2
Regulation
21 CFR 868.5800
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Boulder, CO, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code JOH

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More clearances from Covidien

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Adverse events under product code JOH

product code JOH
Death
42
Injury
1,344
Malfunction
5,608
Other
1
Total
6,995

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K150844

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150844.

Data sourced from openFDA. This site is unofficial and independent of the FDA.