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. Device class: 2.
Summary
The Health Line Tearaway Introducer from Health Line International is filed under DYB, catheter introducers. The record gives no sizes or model numbers.
Class II, 21 CFR 870.1340. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k).
Health Line filed from Salt Lake City, Utah. The decision came 12 calendar days after receipt (June 10 to June 22, 2026). The record flags it as a third-party review.
Clearance details
- Applicant
- Health Line International Corporation
- Product code
- Product code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code DYB
view allMore clearances from Health Line International Corporation
view allAdverse 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.