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FDA 510(k)

ARTLINE

K-Number: K160448 · 2016-07-12

ApplicantHealth Line International Corporation
Decision Date2016-07-12
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARTLINE is the device name listed in this FDA 510(k) record. The listed applicant is Health Line International Corporation. It received FDA 510(k) clearance on 2016-07-12 under 510(k) number K160448. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTLINE?

ARTLINE is a medical device that received FDA 510(k) clearance on 2016-07-12. The listed applicant is Health Line International Corporation. The 510(k) number is K160448.

When did ARTLINE receive FDA 510(k) clearance?

ARTLINE received FDA 510(k) clearance on 2016-07-12, under 510(k) number K160448.

Who is the listed applicant for ARTLINE?

The FDA 510(k) record lists Health Line International Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTLINE?

The FDA product code for ARTLINE is DQY.

Other records listing Health Line International Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261950Health Line Tearaway IntroducerK222170Power Acute Triple Lumen Hemodialysis CatheterK200426Acute Dual Lumen Hemodialysis CatheterK200263Health Line CT Midline CatheterK192533Health Line CT CVC

Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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