Af 620 Ph.I.S.I.O., Af 640 Ph.I.S.I.O. Arterial Filters
FDA 510(k) K093986 · Sorin Group Italia S.R.L.
510(k) numberK093986
Submission
- Device name
- Af 620 Ph.I.S.I.O., Af 640 Ph.I.S.I.O. Arterial Filters
- Applicant
- Sorin Group Italia S.R.L.
Waltham, MA, US - Received
- December 24, 2009
- Decision date
- January 22, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K100646 | Affinity Pixie Arterial Filter with Balance BiosurfaceDTM · Traditional | Medtronic, Inc. | 12/16/2010SE |
| 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 |
|---|---|---|
| K253671 | Dual Stage Venous CannulaeDWF · Traditional | 01/30/2026SE |
| K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirsDTN · Traditional | 12/22/2025SE |
| K253616 | ProtekDilate Vascular Access KitDRE · Special | 12/19/2025SE |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)DWF · Special | 06/27/2025SE |
| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD…DTR · Special | 05/30/2025SE |
| K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14…KDI · Traditional | 04/25/2025SE |
| K242953 | KIDS Arterial FiltersDTM · Special | 12/20/2024SE |
| K242092 | MICRO Arterial FiltersDTM · Special | 11/18/2024SE |
| K241236 | XTRA Collection sets; XTRA Sequestration set XCAC · Special | 08/16/2024SE |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets)CAC · Special | 04/29/2024SE |
Questions and answers
When was Af 620 Ph.I.S.I.O., Af 640 Ph.I.S.I.O. Arterial Filters cleared by the FDA?
Af 620 Ph.I.S.I.O., Af 640 Ph.I.S.I.O. Arterial Filters (K093986) received a 510(k) decision of Substantially Equivalent on January 22, 2010, 29 days after the submission was received.
What is the product code of K093986?
The FDA product code is DTM – Filter, Blood, Cardiopulmonary Bypass, Arterial Line, a Class II (moderate risk) device regulated under 21 CFR 870.4260.