Interface Arterial Blood Filter, Model 42
FDA 510(k) K862591 · Medical, Inc.
510(k) numberK862591
Submission
- Device name
- Interface Arterial Blood Filter, Model 42
- Applicant
- Medical, Inc.
Inver Grove Heights, MN, US - Received
- July 7, 1986
- Decision date
- September 4, 1986
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K082311 | Exsudex Wound Drainage PumpOMP · Abbreviated | 10/08/2008SE |
| K926454 | Anesthesia Respiratory Breath Circuit Packs/ComponCAI · Traditional | 06/22/1993SEKD |
| K894839 | OS-1 Occlusion System - 1BZC · Traditional | 10/24/1989SE |
| K872001 | Model TPC-1A Oxygen AnalyzerCCL · Traditional | 06/15/1987SE |
| K863806 | Model A-1 Oxygen AnalyzerCCL · Traditional | 10/15/1986SE |
| K862609 | Interface Arterial Blood Filter, Model 44DTM · Traditional | 09/04/1986SE |
| K861226 | Interface Crystalloid Cardioplegic Filter Model 70KRJ · Traditional | 06/02/1986SE |
| K851370 | Interface Transfusion Blood Filter #35CAK · Traditional | 06/27/1985SE |
| K823261 | Interface Transfusion Blood Filter #30CAK · Traditional | 01/07/1983SE |
| K823260 | Interface Cardiotomy Blood Filter #51JOD · Traditional | 11/24/1982SE |
Questions and answers
When was Interface Arterial Blood Filter, Model 42 cleared by the FDA?
Interface Arterial Blood Filter, Model 42 (K862591) received a 510(k) decision of Substantially Equivalent on September 4, 1986, 59 days after the submission was received.
What is the product code of K862591?
The FDA product code is DTM – Filter, Blood, Cardiopulmonary Bypass, Arterial Line, a Class II (moderate risk) device regulated under 21 CFR 870.4260.