IL 7F FLOW DIRECTOR THERMAL DILU. CATH— 510(k) K820702
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K820702 for IL 7F FLOW DIRECTOR THERMAL DILU. CATH, Substantially Equivalent on 1982-04-21. Applicant: Instrumentation Laboratory CO.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code DYG
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code DYG
product code DYG- Death
- 18
- Malfunction
- 1,051
- Other
- 1
- Total
- 1,070
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.