Intersept 40 Micron Filter
FDA 510(k) K833477 · Extracorporeal Medical Specialities, Inc.
510(k) numberK833477
Submission
- Device name
- Intersept 40 Micron Filter
- Applicant
- Extracorporeal Medical Specialities, Inc.
Mchenry, IL, US - Received
- October 7, 1983
- Decision date
- December 27, 1983
- 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 |
|---|---|---|
| K843955 | Extracorporeal Maxima Hollow Fiber OxygenatorDTZ · Traditional | 11/29/1984SE |
| K840532 | Hemoperfusion System TP-400FLD · Traditional | 05/30/1984SE |
| K840262 | Hancock Pericardial PatchDXZ · Traditional | 05/30/1984SE |
| K840146 | Exp* 700 Parallel Plate DialyzerKOC · Traditional | 02/04/1984SE |
| K840057 | Exp* 500 Parallel Plate DialyzerKOC · Traditional | 02/04/1984SE |
| K832547 | Ultrafiltration ControllerKDI · Traditional | 01/03/1984SE |
| K831423 | Therapeutic Exchange SystemLQQ · Traditional | 01/03/1984SE |
| K833476 | Intersept 40 Micron Filter W/TubingDTM · Traditional | 12/27/1983SE |
| K831424 | Therapeutic Exchange Blood TUBING-TP-101FJK · Traditional | 10/14/1983SE |
| K832053 | Single Patient Sys. II Model DM-450KOC · Traditional | 09/29/1983SE |
Questions and answers
When was Intersept 40 Micron Filter cleared by the FDA?
Intersept 40 Micron Filter (K833477) received a 510(k) decision of Substantially Equivalent on December 27, 1983, 81 days after the submission was received.
What is the product code of K833477?
The FDA product code is DTM – Filter, Blood, Cardiopulmonary Bypass, Arterial Line, a Class II (moderate risk) device regulated under 21 CFR 870.4260.