SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE— 510(k) K810106
Substantially EquivalentShiley, Inc.
FDA 510(k) clearance K810106 for SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE, Substantially Equivalent on 1981-02-02. Applicant: Shiley, Inc.. Device class: 2.
Clearance details
- Applicant
- Shiley, Inc.
- Product code
- Code BTO
- Device class
- Class 2
- Regulation
- 21 CFR 868.5800
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from Shiley, Inc.
view allAdverse events under product code BTO
product code BTO- Death
- 14
- Injury
- 328
- Malfunction
- 1,851
- Total
- 2,193
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.