Pall Stat-Prime D Blood Filter for Extracorporeal Service
FDA 510(k) K980762 · Pall Corp.
510(k) numberK980762
Submission
- Device name
- Pall Stat-Prime D Blood Filter for Extracorporeal Service
- Applicant
- Pall Corp.
East Hills, NY, US - Received
- February 27, 1998
- Decision date
- September 1, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K211286 | Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture ExchangerCAH · Traditional | 11/16/2021SE |
| K022167 | Pall Doner Pre-Evacuated Post-Operative Autologous Blood Reinfusion SystemCAC · Traditional | 03/07/2003SE |
| K993379 | Pall Supor Aef FilterFPB · Traditional | 12/16/1999SE |
Questions and answers
When was Pall Stat-Prime D Blood Filter for Extracorporeal Service cleared by the FDA?
Pall Stat-Prime D Blood Filter for Extracorporeal Service (K980762) received a 510(k) decision of Substantially Equivalent on September 1, 1998, 186 days after the submission was received.
What is the product code of K980762?
The FDA product code is DTM – Filter, Blood, Cardiopulmonary Bypass, Arterial Line, a Class II (moderate risk) device regulated under 21 CFR 870.4260.