Health Line Tearaway Introducer
Summary
Health Line International Corporation received 510(k) clearance for Health Line Tearaway Introducer, a DYB device. Cleared on 2026-06-22.
Details
Source
510(k) Clearance
External ID
K261950
Action Date
2026-06-22
Status
Traditional
Category
device
Product Code
DYB
Product Description
Health Line Tearaway Introducer. Product code: DYB.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 389 device clearances issued this month. Health Line International Corporation has received 2 total clearances in our database.
Health Line International Corporation has 2 FDA actions in our database, including 2 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Health Line International Corporation have FDA actions?
Health Line International Corporation has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K261950" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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