Arterial Blood Filter Electro. Air* Star 40 and 20
FDA 510(k) K902723 · Electromedics, Inc.
510(k) numberK902723
Submission
- Device name
- Arterial Blood Filter Electro. Air* Star 40 and 20
- Applicant
- Electromedics, Inc.
Englewood, CO, US - Received
- June 19, 1990
- Decision date
- December 13, 1990
- 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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|---|---|---|---|
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| 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 |
|---|---|---|
| K073616 | Fas-Clean Electrosurgical Coated Active BladeGEI · Traditional | 07/23/2008SE |
| K934964 | Electromedics Tympanic Temperature SensorFLL · Traditional | 03/07/1994SE |
| K933832 | Electromedics HG (Hydrogel) Series Skin Temperature SensorFLL · Traditional | 01/28/1994SE |
| K934355 | Electromedics Blood Heat ExchangerDTR · Traditional | 12/03/1993SE |
| K930154 | EL2-SERIES Blood Collection ReervoirDTN · Traditional | 07/01/1993SE |
| K926250 | Electromedics El-Series Cardiotomy ReservoirDTN · Traditional | 02/19/1993SE |
| K925412 | Electromedics Tissue Trap/ #TT280BYZ · Traditional | 02/05/1993SE |
| K915737 | Autotransfusion Blood Collection ReservoirDTN · Traditional | 09/03/1992SE |
| K910238 | Portable Auto Transfusion System 500CAC · Traditional | 06/19/1991SE |
| K910935 | Modified Pyrogen TestingDTM · Traditional | 05/16/1991SE |
Questions and answers
When was Arterial Blood Filter Electro. Air* Star 40 and 20 cleared by the FDA?
Arterial Blood Filter Electro. Air* Star 40 and 20 (K902723) received a 510(k) decision of Substantially Equivalent on December 13, 1990, 177 days after the submission was received.
What is the product code of K902723?
The FDA product code is DTM – Filter, Blood, Cardiopulmonary Bypass, Arterial Line, a Class II (moderate risk) device regulated under 21 CFR 870.4260.