WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL
FDA 510(k) clearance K110269 · decided 2011-08-26
Clearance details
- K-number
- K110269
- Device name
- WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL
- Applicant
- Well Lead Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-01-27
- Decision date
- 2011-08-26
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- BTR
- Device class
- 2
- Regulation number
- 868.5730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Appollo Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethan recall (Z-1876-2024) | MEDLINE INDUSTRIES, LP - Northfield | 2024-05-28 |
| Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product recall (Z-2243-2016) | Parker Medical | 2016-07-19 |