DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE
FDA 510(k) clearance K934465 · decided 1994-01-14
Clearance details
- K-number
- K934465
- Device name
- DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE
- Applicant
- Smiths Industries Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-09-13
- Decision date
- 1994-01-14
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- BTR
- Device class
- 2
- Regulation number
- 868.5730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Keene, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Portex Tracheostomy Tube Decannulation Cap for use only with Fenestrated Tracheostomy Tube recall (Z-0228-05) | Smiths Medical ASD, Inc. | 2004-11-24 |
| Portex Lo-Profile Tracheostomy Tube Decannulation Cap Catalog Number: 582000 recall (Z-0229-05) | Smiths Medical ASD, Inc. | 2004-11-24 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER (P890024/S005) | Smiths Industries Medical Systems, Inc. | 1993-12-27 |
| TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER (P890024/S003) | Smiths Industries Medical Systems, Inc. | 1992-04-21 |
| TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER (P890024/S004) | Smiths Industries Medical Systems, Inc. | 1992-04-21 |
| TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER (P890024/S002) | Smiths Industries Medical Systems, Inc. | 1992-02-25 |
| TROPHOCAN TM (P890024/S001) | Smiths Industries Medical Systems, Inc. | 1990-08-17 |
| TROPHOCAN TM (P890024) | Smiths Industries Medical Systems, Inc. | 1990-08-09 |