Health Line Tearaway Introducer— 510(k) K261950

Name: FDA 510(k) clearance K261950
Creator: U.S. Food and Drug Administration
Published: 2026-06-22

Substantially Equivalent

Health 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.

Clearance details

Applicant: Health Line International Corporation
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2026-06-10
Decision date: 2026-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYB

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K253526 — NAMIC Dilator and Sheath2026-07-29
K261529 — Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C) +2 more2026-07-06
K261242 — SimplGuide2026-06-25
K261492 — FieldFlex Steerable Sheath2026-06-05
K260606 — Echo Large Bore Introducer Sheath2026-04-29

More clearances from Health Line International Corporation

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K222170 — Power Acute Triple Lumen Hemodialysis Catheter2023-01-13
K200426 — Acute Dual Lumen Hemodialysis Catheter2020-12-24
K200263 — Health Line CT Midline Catheter2020-03-12
K192533 — Health Line CT CVC2019-12-10
K160448 — ARTLINE2016-07-12

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, 2020-01-01 through 2026-04-23. 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.