PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)— 510(k) K960993
Substantially EquivalentPall Biomedical Products Co.
FDA 510(k) clearance K960993 for PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST), Substantially Equivalent on 1996-04-22. Applicant: Pall Biomedical Products Co.. Device class: 2.
Clearance details
- Applicant
- Pall Biomedical Products Co.
- Product code
- Code CAK
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Hills, NY, US
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More clearances from Pall Biomedical Products Co.
view allAdverse events under product code CAK
product code CAK- Malfunction
- 476
- Total
- 476
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K960993
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K960993.
Data sourced from openFDA. This site is unofficial and independent of the FDA.