ARTERIAL BLOOD SAMPLING KIT
FDA 510(k) clearance K902771 · decided 1990-11-05
Clearance details
- K-number
- K902771
- Device name
- ARTERIAL BLOOD SAMPLING KIT
- Applicant
- Medex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-06-21
- Decision date
- 1990-11-05
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- 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 |
|---|---|---|
| Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medi recall (Z-0695-2008) | Smiths Medical Asd Inc | 2008-01-31 |
| Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4033, Smiths Medi recall (Z-0696-2008) | Smiths Medical Asd Inc | 2008-01-31 |
| MX20170: Pediatric 40 In Sampling Kit w/10cc syringe, MX20443: LogiCal Single Pressure Kit recall (Z-0198-05) | Medex Inc | 2004-11-16 |