TRACHEOLIFE
FDA 510(k) clearance K941535 · decided 1994-04-15
Clearance details
- K-number
- K941535
- Device name
- TRACHEOLIFE
- Applicant
- Mallinckrodt Medical
- Decision
- Substantially Equivalent
- Date received
- 1994-03-30
- Decision date
- 1994-04-15
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- BYD
- Device class
- 1
- Regulation number
- 868.5375
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Argyle, NY, US
- Third-party review
- No
- Expedited review
- No
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| HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE (K953491) | Gibeck, Inc. | 1995-08-25 |
| WARM N WET HMEF W/LUER ADAPTER (K953620) | Hospitak, Inc. | 1995-08-25 |
| EEE (K953540) | Edentec Corp. | 1995-08-25 |
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| HUMID-VENT TRACH-VENT (K952845) | Gibeck, Inc. | 1995-07-25 |
| HUMID-VENT 2 (K952844) | Gibeck, Inc. | 1995-07-20 |
| HUMID-VENT 1 (K952750) | Gibeck, Inc. | 1995-07-20 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated f recall (Z-1868-2021) | Covidien, LP | 2021-06-16 |