Pall SQ40S Blood Filter (SQ40S/SQ40ST)
FDA 510(k) K960993 · Pall Biomedical Products Co.
510(k) numberK960993
Submission
- Device name
- Pall SQ40S Blood Filter (SQ40S/SQ40ST)
- Applicant
- Pall Biomedical Products Co.
East Hills, NY, US - Received
- March 12, 1996
- Decision date
- April 22, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CAK – Microfilter, Blood Transfusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code CAK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061103 | Haemonetics 40U RBC Filter BagCAK · Traditional | Haemonetics Corp. | 05/17/2006SE |
| K022477 | Summit Medical Ltd Transfusion Filter, Model LF400 & Summit Medical Ltd Transfusion…CAK · Traditional | Summit Medical , Ltd. | 10/25/2002SE |
| K000719 | Neocare 20 Micron Blood FilterCAK · Traditional | Whatman, Inc. | 05/30/2000SE |
| K990310 | Charter Medical, Ltd MP 450 (40 Micron Filter)CAK · Traditional | Charter Medical, Ltd. | 08/30/1999SE |
| K982822 | Fenwal 20 Micron Pediatric Transfusion Filter Model 4C7701, Fenwal 20 Micron Pediatric…CAK · Traditional | Baxter Healthcare Corp | 09/30/1998SE |
| K972159 | Fenwal 40 Micron Transfusion FilterCAK · Traditional | Baxter Healthcare Corp | 07/23/1997SE |
| K970225 | Alpha Micron 20/40 Microaggregate FilterCAK · Traditional | Alpha Therapeutic Corp. | 02/14/1997SE |
| K955515 | Alpha Micron 20 Microaggregate FilterCAK · Traditional | Alpha Therapeutic Corp. | 02/12/1996SE |
| K904223 | Sepacell(R) R-200/500 Leukocyte Removal Recip SetsCAK · Traditional | Baxter Healthcare Corp | 10/26/1990SE |
| K904221 | Sepacell(R) PL-5A/10A Leukocyte Removal FiltersCAK · Traditional | Baxter Healthcare Corp | 10/26/1990SE |
More from Baxter Healthcare Corp
| 510(k) | Device | Decision |
|---|---|---|
| K954331 | Pall Lea Filter (Lipid Emulsion Filter) (I.V. Filter)FPB · Traditional | 01/09/1997SE |
| K905794 | Pall 3N1 FilterFPB · Traditional | 06/13/1991SE |
| K902518 | Ld-Six Arterial Blood Filter for Extra. ServiceDTM · Traditional | 10/16/1990SE |
| 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 Pall SQ40S Blood Filter (SQ40S/SQ40ST) cleared by the FDA?
Pall SQ40S Blood Filter (SQ40S/SQ40ST) (K960993) received a 510(k) decision of Substantially Equivalent on April 22, 1996, 41 days after the submission was received.
What is the product code of K960993?
The FDA product code is CAK – Microfilter, Blood Transfusion, a Class II (moderate risk) device regulated under 21 CFR 880.5440.