Arterial Blood Filter BF-37
FDA 510(k) K802755 · Delta Medical Industries
510(k) numberK802755
Submission
- Device name
- Arterial Blood Filter BF-37
- Applicant
- Delta Medical Industries
Mchenry, IL, US - Received
- November 3, 1980
- Decision date
- January 7, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Sorin Group Italia S.R.L.
| 510(k) | Device | Decision |
|---|---|---|
| K833884 | Isotec Dispos. Pressure Transducer · Traditional | 04/17/1984SE |
| K840253 | One-Way Air ValveBYZ · Traditional | 04/05/1984SE |
| K832470 | Infusion PumpFRN · Traditional | 02/28/1984SE |
| K830389 | Accu-Rynge Pump SP-250FRN · Traditional | 09/12/1983SE |
| K831750 | PM-3DXS · Traditional | 07/26/1983SE |
| K822761 | Delivery Tube Set #2226FRN · Traditional | 09/30/1982SE |
| K820912 | PMS-2 Pressure Monitor SeparatorDXS · Traditional | 05/18/1982SE |
| K820482 | Accu-Rynge Insulin Pump #SP-250FRN · Traditional | 03/26/1982SE |
| K810068 | Pediatric Arterial Blood FilterDTM · Traditional | 01/22/1981SE |
| K803102 | Arterial Bubble Trap K-20KRL · Traditional | 12/22/1980SE |
Questions and answers
When was Arterial Blood Filter BF-37 cleared by the FDA?
Arterial Blood Filter BF-37 (K802755) received a 510(k) decision of Substantially Equivalent on January 7, 1981, 65 days after the submission was received.
What is the product code of K802755?
The FDA product code is DTM – Filter, Blood, Cardiopulmonary Bypass, Arterial Line, a Class II (moderate risk) device regulated under 21 CFR 870.4260.