MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT— 510(k) K896664
Substantially EquivalentAsahi Medical Co., Ltd.
FDA 510(k) clearance K896664 for MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT, Substantially Equivalent on 1990-01-24. Applicant: Asahi Medical Co., Ltd..
Clearance details
- Applicant
- Asahi Medical Co., Ltd.
- Product code
- Code CAK
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.