Health Line CT Midline Catheter— 510(k) K200263
Substantially EquivalentHealth Line International Corporation
FDA 510(k) clearance K200263 for Health Line CT Midline Catheter, Substantially Equivalent on 2020-03-12. Applicant: Health Line International Corporation.
Clearance details
- Applicant
- Health Line International Corporation
- Product code
- Code FOZ
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Salt Lake City, UT, US
Adverse events under product code FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
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.