TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE— 510(k) K851856
Substantially EquivalentSheridan Catheter Corp.
FDA 510(k) clearance K851856 for TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE, Substantially Equivalent on 1985-05-23. Applicant: Sheridan Catheter Corp.. Device class: 2.
Clearance details
- Applicant
- Sheridan Catheter Corp.
- 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
- Argyle, NY, US
Recent devices under product code CBI
view allMore clearances from Sheridan Catheter Corp.
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 →
Recalls naming K851856
K-number listed on FDA's recall record- Z-0703-2020 — HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The Sheridan Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
- Z-2368-2015 — HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K851856.
Data sourced from openFDA. This site is unofficial and independent of the FDA.