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

Substantially Equivalent

Stryker Instruments

FDA 510(k) clearance K970714 for STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII), Substantially Equivalent on 1997-12-16. Applicant: Stryker Instruments.

Clearance details

Applicant: Stryker Instruments
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 1997-02-27
Decision date: 1997-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAC

product code CAC

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.