Artline

FDA 510(k) K160448 · Health Line International Corporation

Substantially Equivalent

510(k) numberK160448

Submission

Device name
Artline
Applicant
Health Line International Corporation
Salt Lake City, UT, US
Received
February 18, 2016
Decision date
July 12, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQY – Catheter, Percutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Specialty
Cardiovascular

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Questions and answers

When was Artline cleared by the FDA?

Artline (K160448) received a 510(k) decision of Substantially Equivalent on July 12, 2016, 145 days after the submission was received.

What is the product code of K160448?

The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.