PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE— 510(k) K855065
Substantially EquivalentCobe Laboratories, Inc.
FDA 510(k) clearance K855065 for PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE, Substantially Equivalent on 1986-02-28. Applicant: Cobe Laboratories, Inc..
Clearance details
- Applicant
- Cobe Laboratories, Inc.
- Product code
- Code FPB
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
Adverse events under product code FPB
product code FPB- Other
- 1
- Total
- 1
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.