AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE— 510(k) K100646
Substantially EquivalentMedtronic, Inc.
FDA 510(k) clearance K100646 for AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE, Substantially Equivalent on 2010-12-16. Applicant: Medtronic, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic, 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
- Traditional
- Location
- Minneapolis, MN, US
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