AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE— 510(k) K123351
Substantially EquivalentMedtronic Perfusion Systems
FDA 510(k) clearance K123351 for AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE, Substantially Equivalent on 2013-03-19. 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
- Traditional
- Location
- Minneapolis, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.