FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
K Number: K123351
·
Decision Mar 19, 2013
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
94
Applicant Total
28
Review Days
139
Basic Information
- Device Name
- AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
- K Number
- K123351
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4260
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDTRONIC PERFUSION SYSTEMS
- Date Received
- October 31, 2012
- Decision Date
- March 19, 2013
- Product Code
- DTM
- 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 |
|---|---|---|---|
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DTM), ordered by most recent decision date.
KIDS Arterial Filters
FDA 510(k)
FDA Class 2
·Cardiovascular
MICRO Arterial Filters
FDA 510(k)
FDA Class 2
·Cardiovascular
OCS Heart Leukocyte Depleting Filter
FDA 510(k)
FDA Class 2
·Cardiovascular
AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
FDA 510(k)
FDA Class 2
·Cardiovascular
TERUMO PALL AL20X ARTERIAL FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
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 |
| 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 |
| K050109 | TRILLIUM BIOPUMP PLUS, MODEL BPX80T | Feb 11, 2005 | Substantially Equivalent |