Sheridan Endobronchial Tubes— 510(k) K180253
Substantially EquivalentTeleflex Medical
FDA 510(k) clearance K180253 for Sheridan Endobronchial Tubes, Substantially Equivalent on 2018-11-02. Applicant: Teleflex Medical. Device class: 2.
Clearance details
- Applicant
- Teleflex Medical
- Product code
- Code CBI
- Device class
- Class 2
- Regulation
- 21 CFR 868.5740
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morrisville, NC, US
Recent devices under product code CBI
view allMore clearances from Teleflex Medical
view allAdverse events under product code CBI
product code CBI- Death
- 4
- Malfunction
- 594
- Total
- 598
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.