Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811) +2 more— 510(k) K240666
Substantially EquivalentMedtronic Perfusion Systems
FDA 510(k) clearance K240666 for Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811) +2 more, Substantially Equivalent on 2024-07-10. Applicant: Medtronic Perfusion Systems. Device class: 2.
Clearance details
- Device name as filed
- Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)
- Applicant
- Medtronic Perfusion Systems
- Product code
- Code DTZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4350
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code DTZ
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More clearances from Medtronic Perfusion Systems
view all- K181954 — autoLog IQ Autotransfusion System
- K123351 — AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
- K101186 — AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
- K090869 — MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD
- K080824 — BIO-CONSOLE 560
Adverse events under product code DTZ
product code DTZ- Death
- 182
- Injury
- 422
- Malfunction
- 3,636
- Total
- 4,240
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.