Health Line Tearaway Introducer— 510(k) K261950
Substantially EquivalentHealth Line International Corporation
FDA 510(k) clearance K261950 for Health Line Tearaway Introducer, Substantially Equivalent on 2026-06-22. Applicant: Health Line International Corporation.
Clearance details
- Applicant
- Health Line International Corporation
- Product code
- Code DYB
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Adverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
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.