TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE
FDA 510(k) clearance K851856 · decided 1985-05-23
Clearance details
- K-number
- K851856
- Device name
- TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE
- Applicant
- Sheridan Catheter Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-26
- Decision date
- 1985-05-23
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- CBI
- Device class
- 2
- Regulation number
- 868.5740
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Argyle, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr recall (Z-2368-2015) | Teleflex Medical | 2015-08-20 |
| Sheridan Sher-I-Bronch Left Endobronchial Tube; an Rx, sterile, sinlge use endobronchial t recall (Z-0680-05) | Teleflex Medical | 2005-04-06 |
| Sheridan Sher-I-Bronch Endobronchial Tube for Right Bronchial Intubation; an Rx, sterile, recall (Z-0681-05) | Teleflex Medical | 2005-04-06 |