COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD— 510(k) K982254
Substantially EquivalentCobe Cardiovascular, Inc.
FDA 510(k) clearance K982254 for COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD, Substantially Equivalent on 1998-09-10. Applicant: Cobe Cardiovascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Cobe Cardiovascular, Inc.
- Product code
- Code DTM
- Device class
- Class 2
- Regulation
- 21 CFR 870.4260
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Arvada, CO, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.