ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR
FDA 510(k) clearance K790312 · decided 1979-02-21
Clearance details
- K-number
- K790312
- Device name
- ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR
- Applicant
- Respiratory Support Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-02-13
- Decision date
- 1979-02-21
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- BTR
- Device class
- 2
- Regulation number
- 868.5730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/1 recall (Z-1289-2025) | Smiths Medical ASD, Inc. | 2025-03-12 |
| 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Int recall (Z-2536-2014) | Smiths Medical ASD, Inc. | 2014-08-28 |
| H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal recall (Z-2537-2014) | Smiths Medical ASD, Inc. | 2014-08-28 |
| H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal In recall (Z-2538-2014) | Smiths Medical ASD, Inc. | 2014-08-28 |
| H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal recall (Z-2539-2014) | Smiths Medical ASD, Inc. | 2014-08-28 |
| Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used recall (Z-1641-2014) | Smiths Medical ASD, Inc. | 2014-06-11 |