FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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)
K Number: K240666
·
Decision Jul 10, 2024
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
253
Applicant Total
29
Review Days
124
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Basic Information
- Device Name
- 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)
- K Number
- K240666
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4350
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Perfusion Systems
- Date Received
- March 8, 2024
- Decision Date
- July 10, 2024
- Product Code
- DTZ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
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Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
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Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Medtronic Perfusion Systems
| K Number | Device Name | ||
|---|---|---|---|
| K181954 | autoLog IQ Autotransfusion System | Aug 22, 2018 | Substantially Equivalent |
| K123351 | AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE | Mar 19, 2013 | Substantially Equivalent |
| K101186 | AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG | Sep 3, 2010 | Substantially Equivalent |
| K090869 | MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD | Aug 27, 2009 | Substantially Equivalent |
| K080824 | BIO-CONSOLE 560 | May 7, 2008 | Substantially Equivalent |
| K061254 | EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 | Jun 23, 2006 | Substantially Equivalent |
| K052524 | BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT | Nov 22, 2005 | Substantially Equivalent |
| K052372 | MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C | Sep 22, 2005 | Substantially Equivalent |
| K051303 | BIO-CONSOLE, MODEL 560 | Jun 10, 2005 | Substantially Equivalent |
| K051040 | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | May 24, 2005 | Substantially Equivalent |