STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)— 510(k) K970714

Clearance details

Applicant

Stryker Instruments

Product code

Code CAC

Device class

Class 2

Regulation

21 CFR 868.5830

Advisory panel

Anesthesiology

Date received

1997-02-27

Decision date

1997-12-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Kalamazoo, MI, US

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Death

11

Malfunction

477

Total

488

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1570-2015 — 3/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20150326
• Z-1571-2015 — 1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20150326
• Z-1572-2015 — 1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20150326
• Z-1573-2015 — Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp and the female connector. The rigid polycarbonate female connector is used to connect the ambulating bulb to the CBCII evacuator tube in order to collect wound drainage.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20150326

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970714.