REGIONAL ANESTHESIA TRAYS
FDA 510(k) clearance K965017 · decided 1997-03-14
Clearance details
- K-number
- K965017
- Device name
- REGIONAL ANESTHESIA TRAYS
- Applicant
- Smiths Industries Medical Systems, Inc.
- Decision
- Unknown
- Date received
- 1996-12-16
- Decision date
- 1997-03-14
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- CAZ
- Device class
- 2
- Regulation number
- 868.5140
- 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 Spinal Tray, Item No. A3729-24 A3595 recall (Z-1101-2026) | ICU Medical Inc. | 2026-01-15 |
| Portex Continuous Epidural tray Ref 4948-17 recall (Z-0211-2007) | Smiths Medical ASD, Inc. | 2006-11-22 |
| 4902 Glass L.O.R. Syringe recall (Z-0242-06) | Smiths Medical ASD, Inc. | 2005-11-30 |
| 4903 Glass L.O.R. Syringe recall (Z-0243-06) | Smiths Medical ASD, Inc. | 2005-11-30 |
| 4904 Glass L.O.R. Syringe recall (Z-0244-06) | Smiths Medical ASD, Inc. | 2005-11-30 |
| 4950-16 Portex Epidural Mini-pack recall (Z-0245-06) | Smiths Medical ASD, Inc. | 2005-11-30 |
| Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epineph recall (Z-0166-04) | Portex Inc | 2003-11-27 |
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 |