NEOCARE 20 MICRON BLOOD FILTER— 510(k) K000719
Substantially EquivalentWhatman, Inc.
FDA 510(k) clearance K000719 for NEOCARE 20 MICRON BLOOD FILTER, Substantially Equivalent on 2000-05-30. Applicant: Whatman, Inc.. Device class: 2.
Clearance details
- Applicant
- Whatman, Inc.
- 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
- Ann Arbor, MI, US
Recent devices under product code CAK
view all- K061103 — HAEMONETICS 40U RBC FILTER BAG
- K022477 — SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET
- K990310 — CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)
- K982822 — FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72
- K972159 — FENWAL 40 MICRON TRANSFUSION FILTER
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.