Affinity AF100 Arterial Filter with Carmeda Bioactive Surface
FDA 510(k) K123351 · Medtronic Perfusion Systems
510(k) numberK123351
Submission
- Device name
- Affinity AF100 Arterial Filter with Carmeda Bioactive Surface
- Applicant
- Medtronic Perfusion Systems
Minneapolis, MN, US - Received
- October 31, 2012
- Decision date
- March 19, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTM – Filter, Blood, Cardiopulmonary Bypass, Arterial Line
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4260
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251744 | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial…DTM · Special | Medtronic | 01/16/2026SE |
| K242953 | KIDS Arterial FiltersDTM · Special | Sorin Group Italia S.R.L. | 12/20/2024SE |
| K242092 | MICRO Arterial FiltersDTM · Special | Sorin Group Italia S.R.L. | 11/18/2024SE |
| K231362 | OCS Heart Leukocyte Depleting FilterDTM · Traditional | TransMedics, Inc. | 10/31/2023SE |
| K122760 | Affinity AF100 Arterial Filter with Balance BiosurfaceDTM · Traditional | Medtronic, Inc. | 12/07/2012SE |
| K121209 | Terumo Pall AL20X Arterial FilterDTM · Special | Terumo Cardiovascular Systems Corporation | 05/08/2012SE |
| K112525 | D731 Micro 27 Ph.I.S.I.O. and D733 Micro 40 Ph.I.S.O. Arterial FiltersDTM · Special | Parexel International | 09/29/2011SE |
| K100646 | Affinity Pixie Arterial Filter with Balance BiosurfaceDTM · Traditional | Medtronic, Inc. | 12/16/2010SE |
| K093986 | Af 620 Ph.I.S.I.O., Af 640 Ph.I.S.I.O. Arterial FiltersDTM · Special | Sorin Group Italia S.R.L. | 01/22/2010SE |
| K093601 | Af 840 Ph.I.S.I.O. Arterial FilterDTM · Special | Sorin Group Italia S.R.L. | 12/18/2009SE |
More from Sorin Group Italia S.R.L.
| 510(k) | Device | Decision |
|---|---|---|
| K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…DTZ · Traditional | 07/10/2024SE |
| K181954 | autoLog IQ Autotransfusion SystemCAC · Special | 08/22/2018SE |
| K101186 | Affinity Vard Sub-Assembly for CPS (Carmeda Coated), Purgeline (Uncoated), Holding BagDTP · Traditional | 09/03/2010SE |
| K090869 | Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…DWF · Traditional | 08/27/2009SE |
| K080824 | Bio-Console 560DWA · Traditional | 05/07/2008SE |
| K061254 | Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222DWF · Special | 06/23/2006SE |
| K052524 | Bio-Medicus Multi-Stage Venous Femoral Percutaneous KitDWF · Special | 11/22/2005SE |
| K052372 | MC2X Multi-Stage Venous Cannula, Models 91437, 91437CDWF · Special | 09/22/2005SE |
| K051303 | Bio-Console, Model 560DWA · Special | 06/10/2005SE |
| K051040 | Heparin Dose Response Controls, Model 306-20 PorJOX · Special | 05/24/2005SE |
Questions and answers
When was Affinity AF100 Arterial Filter with Carmeda Bioactive Surface cleared by the FDA?
Affinity AF100 Arterial Filter with Carmeda Bioactive Surface (K123351) received a 510(k) decision of Substantially Equivalent on March 19, 2013, 139 days after the submission was received.
What is the product code of K123351?
The FDA product code is DTM – Filter, Blood, Cardiopulmonary Bypass, Arterial Line, a Class II (moderate risk) device regulated under 21 CFR 870.4260.