TRACHEAL TUBE STYLET
FDA 510(k) clearance K902180 · decided 1990-07-19
Clearance details
- K-number
- K902180
- Device name
- TRACHEAL TUBE STYLET
- Applicant
- Sims Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-05-15
- Decision date
- 1990-07-19
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- BSR
- Device class
- 1
- Regulation number
- 868.5790
- 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 Tracheal Tube Guide 15 Fr, non-sterile Catalog Number: 153013 recall (Z-0572-04) | Smiths Medical ASD, Inc | 2004-07-20 |
| Portex Inner Cannula for Tracheostomy Tube Size 7.0 mm, REF Code 566070 recall (Z-1016-04) | Smiths Medical ASD, Inc | 2004-07-20 |
| Portex Inner Cannula for Tracheostomy Tube, 8.0 mm, REF Code 566080 recall (Z-1017-04) | Smiths Medical ASD, Inc | 2004-07-20 |