Arterial Blood Filter Model #AF-1040
FDA 510(k) K820343 · Bentley Laboratories, Inc.
510(k) numberK820343
Submission
- Device name
- Arterial Blood Filter Model #AF-1040
- Applicant
- Bentley Laboratories, Inc.
Mchenry, IL, US - Received
- February 8, 1982
- Decision date
- June 17, 1982
- 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 |
|---|---|---|
| K931967 | HE-30 GoldDTR · Traditional | 07/13/1993SE |
| K913956 | Blood Cardioplegia Heat Exchanger, Model #HE-30DTN · Traditional | 01/17/1992SE |
| K913692 | Venous Reservoir Bag Model No. BMR-250(TM)DTN · Traditional | 11/15/1991SE |
| K903641 | Quick Prime Hemoconcen. No. HQ-7000 and CBP-7000QKDI · Traditional | 11/09/1990SE |
| K894826 | Univox W/Holders, Models Univox-Hl, HLB, HLFDTZ · Traditional | 02/28/1990SE |
| K874867 | Catr(Tm)-H Cardiotomy HolderKPI · Traditional | 02/02/1988SE |
| K874841 | Integrated Membrane Oxygenator W/Cardiotomy FilterDTZ · Traditional | 02/02/1988SE |
| K874618 | Baxter Accuport(Tm) Central Venous CatheterDQR · Traditional | 01/19/1988SE |
| K823359 | Oxygen Consumption Monitor #OCM-0100DRY · Traditional | 01/05/1983SE |
| K823273 | BOS-2S, Spiraflo Bubble Infant Oxygen.DTZ · Traditional | 01/05/1983SE |
Questions and answers
When was Arterial Blood Filter Model #AF-1040 cleared by the FDA?
Arterial Blood Filter Model #AF-1040 (K820343) received a 510(k) decision of Substantially Equivalent on June 17, 1982, 129 days after the submission was received.
What is the product code of K820343?
The FDA product code is DTM – Filter, Blood, Cardiopulmonary Bypass, Arterial Line, a Class II (moderate risk) device regulated under 21 CFR 870.4260.