Health Line Tearaway Introducer
FDA 510(k) clearance K261950 · decided 2026-06-22
Clearance details
- K-number
- K261950
- Device name
- Health Line Tearaway Introducer
- Applicant
- Health Line International Corporation
- Decision
- Substantially Equivalent
- Date received
- 2026-06-10
- Decision date
- 2026-06-22
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Salt Lake City, UT, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.