SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM— 510(k) K021830

Substantially Equivalent

Cobe Cardiovascular, Inc.

FDA 510(k) clearance K021830 for SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM, Substantially Equivalent on 2002-07-02. Applicant: Cobe Cardiovascular, Inc..

Clearance details

Applicant: Cobe Cardiovascular, Inc.
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 2002-06-04
Decision date: 2002-07-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Arvada, CO, US

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Adverse events under product code DTR

product code DTR

Other: 1
Total: 1

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.