Ld-Six Arterial Blood Filter for Extra. Service
FDA 510(k) K902518 · Pall Biomedical Products Co.
510(k) numberK902518
Submission
- Device name
- Ld-Six Arterial Blood Filter for Extra. Service
- Applicant
- Pall Biomedical Products Co.
Glen Cove, NY, US - Received
- June 6, 1990
- Decision date
- October 16, 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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| 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 |
|---|---|---|
| K954331 | Pall Lea Filter (Lipid Emulsion Filter) (I.V. Filter)FPB · Traditional | 01/09/1997SE |
| K960993 | Pall SQ40S Blood Filter (SQ40S/SQ40ST)CAK · Traditional | 04/22/1996SE |
| K905794 | Pall 3N1 FilterFPB · Traditional | 06/13/1991SE |
| K884534 | Pall Hepchek (TM) Heparin Absorption FilterJPA · Traditional | 01/24/1989SE |
| K875095 | Pall Cardioplegia Plus Filter W/Posidyne MembraneJOD · Traditional | 02/29/1988SE |
| K875094 | Ultipor Pre-Bypass Plus Filter W/Posidyne MembraneKRJ · Traditional | 02/29/1988SE |
| K873667 | Pall Leukocyte Removal Filter, PlateletsCAK · Traditional | 01/06/1988SE |
| K873666 | Pall Leukocyte Removal Filter, BloodCAK · Traditional | 01/06/1988SE |
| K874405 | Pall Stat Prime(Tm) Blood Filter for Extra. UseJOD · Traditional | 12/30/1987SE |
| K853987 | Pall Ec Plus 3LPM Max. Filter W/SleeveDTM · Traditional | 12/11/1985SE |
Questions and answers
When was Ld-Six Arterial Blood Filter for Extra. Service cleared by the FDA?
Ld-Six Arterial Blood Filter for Extra. Service (K902518) received a 510(k) decision of Substantially Equivalent on October 16, 1990, 132 days after the submission was received.
What is the product code of K902518?
The FDA product code is DTM – Filter, Blood, Cardiopulmonary Bypass, Arterial Line, a Class II (moderate risk) device regulated under 21 CFR 870.4260.