STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
FDA 510(k) clearance K970714 · decided 1997-12-16
Clearance details
- K-number
- K970714
- Device name
- STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
- Applicant
- Stryker Instruments
- Decision
- Substantially Equivalent
- Date received
- 1997-02-27
- Decision date
- 1997-12-16
- Days to decision
- 292 days
- Clearance type
- Traditional
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 3/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with recall (Z-1570-2015) | Stryker Instruments Div. of Stryker Corporation | 2015-05-01 |
| 1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with W recall (Z-1571-2015) | Stryker Instruments Div. of Stryker Corporation | 2015-05-01 |
| 1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with W recall (Z-1572-2015) | Stryker Instruments Div. of Stryker Corporation | 2015-05-01 |
| Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the s recall (Z-1573-2015) | Stryker Instruments Div. of Stryker Corporation | 2015-05-01 |