COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED— 510(k) K993001
Substantially EquivalentCobe Cardiovascular, Inc.
FDA 510(k) clearance K993001 for COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED, Substantially Equivalent on 1999-12-03. Applicant: Cobe Cardiovascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Cobe Cardiovascular, Inc.
- Product code
- Code DTN
- Device class
- Class 2
- Regulation
- 21 CFR 870.4400
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arvada, CO, US
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Adverse events under product code DTN
product code DTN- Death
- 3
- Total
- 3
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.