Affinity Pixie Arterial Filter with Balance Biosurface
FDA 510(k) K100646 · Medtronic, Inc.
510(k) numberK100646
Submission
- Device name
- Affinity Pixie Arterial Filter with Balance Biosurface
- Applicant
- Medtronic, Inc.
Minneapolis, MN, US - Received
- March 5, 2010
- Decision date
- December 16, 2010
- 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 |
| K123351 | Affinity AF100 Arterial Filter with Carmeda Bioactive SurfaceDTM · Traditional | Medtronic Perfusion Systems | 03/19/2013SE |
| 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 |
| 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 |
|---|---|---|
| K262735 | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)MXD · Special | 08/28/2026SE |
| K262005 | Affera Integrated Mapping SystemDQK · Special | 08/21/2026SE |
| K261335 | VitalFlow Set with Balance BiosurfaceQJZ · Traditional | 07/31/2026SE |
| K261866 | Concerto Versa Detachable CoilKRD · Special | 06/24/2026SE |
| K253530 | Trexon Monofilament Synthetic Absorbable SutureGAM · Traditional | 05/28/2026SE |
| K260195 | Elongated One-Piece Arterial (EOPA) 3D Arterial CannulaeDWF · Special | 04/23/2026SE |
| K253203 | Retrograde Coronary Sinus Perfusion CannulaeDWF · Traditional | 02/19/2026SE |
| K253998 | Clearview Intracoronary ShuntsDWF · Special | 01/20/2026SE |
| K251744 | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial…DTM · Special | 01/16/2026SE |
| K251831 | Bio-Medicus Life Support Catheter and IntroducerQHW · Traditional | 01/15/2026SE |
Questions and answers
When was Affinity Pixie Arterial Filter with Balance Biosurface cleared by the FDA?
Affinity Pixie Arterial Filter with Balance Biosurface (K100646) received a 510(k) decision of Substantially Equivalent on December 16, 2010, 286 days after the submission was received.
What is the product code of K100646?
The FDA product code is DTM – Filter, Blood, Cardiopulmonary Bypass, Arterial Line, a Class II (moderate risk) device regulated under 21 CFR 870.4260.