Health Line Tearaway Introducer
FDA 510(k) K261950 · Health Line International Corporation
510(k) numberK261950
Submission
- Device name
- Health Line Tearaway Introducer
- Applicant
- Health Line International Corporation
Salt Lake City, UT, US - Received
- June 10, 2026
- Decision date
- June 22, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K160448 | ArtlineDQY · Traditional | 07/12/2016SE |
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| K130851 | Cascade Hemodialysis/Apheresis CatheterMSD · Traditional | 01/09/2014SESK |
| K130034 | Uni-PiccLJS · Traditional | 03/08/2013SE |
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Questions and answers
When was Health Line Tearaway Introducer cleared by the FDA?
Health Line Tearaway Introducer (K261950) received a 510(k) decision of Substantially Equivalent on June 22, 2026, 12 days after the submission was received.
What is the product code of K261950?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.