PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA
FDA 510(k) clearance K963732 · decided 1997-06-26
Clearance details
- K-number
- K963732
- Device name
- PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA
- Applicant
- Mallinckrodt Medical
- Decision
- Substantially Equivalent
- Date received
- 1996-09-17
- Decision date
- 1997-06-26
- Days to decision
- 282 days
- Clearance type
- Traditional
- Product code
- JOH
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- St Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Shiley Percutaneous Dual Cannula Tracheostomy Tube, 6 PERC, Assembled in Mexico, Tyco Heal recall (Z-1474-2010) | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) | 2010-05-06 |
| Shiley Percutaneous Dual Cannula Tracheostomy Tube, 8 PERC, Assembled in Mexico, Tyco Heal recall (Z-1475-2010) | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) | 2010-05-06 |