SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM— 510(k) K021830
Substantially EquivalentCobe 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.. Device class: 2.
Clearance details
- Applicant
- Cobe Cardiovascular, Inc.
- Product code
- Code DTR
- Device class
- Class 2
- Regulation
- 21 CFR 870.4240
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- 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, through . 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.