TRANSTAR PRESSURE TRANSDUCER
FDA 510(k) clearance K942377 · decided 1994-08-16
Clearance details
- K-number
- K942377
- Device name
- TRANSTAR PRESSURE TRANSDUCER
- Applicant
- Medex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-05-18
- Decision date
- 1994-08-16
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- DPT
- Device class
- 2
- Regulation number
- 870.2120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hilliard, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086 recall (Z-0184-2025) | Smiths Medical ASD, Inc. | 2024-10-23 |
| medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1 recall (Z-0185-2025) | Smiths Medical ASD, Inc. | 2024-10-23 |
| medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740 recall (Z-0186-2025) | Smiths Medical ASD, Inc. | 2024-10-23 |