AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354— 510(k) K994208
Substantially EquivalentMedtronic Perfusion Systems
FDA 510(k) clearance K994208 for AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354, Substantially Equivalent on 2000-01-13. Applicant: Medtronic Perfusion Systems. Device class: 2.
Clearance details
- Applicant
- Medtronic Perfusion Systems
- 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
- Special
- Location
- Minneapolis, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.