SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM— 510(k) K012763

Substantially Equivalent

Cobe Cardiovascular, Inc.

FDA 510(k) clearance K012763 for SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM, Substantially Equivalent on 2001-11-15. Applicant: Cobe Cardiovascular, Inc..

Clearance details

Applicant: Cobe Cardiovascular, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 2001-08-17
Decision date: 2001-11-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Arvada, CO, US

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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.