AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG— 510(k) K101186
Substantially EquivalentMedtronic Perfusion Systems
FDA 510(k) clearance K101186 for AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG, Substantially Equivalent on 2010-09-03. Applicant: Medtronic Perfusion Systems. Device class: 2.
Clearance details
- Applicant
- Medtronic Perfusion Systems
- Product code
- Code DTP
- Device class
- Class 2
- Regulation
- 21 CFR 870.4230
- 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.