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FDA 510(k)

Health Line CT CVC

K-Number: K192533 · 2019-12-10

ApplicantHealth Line International Corporation
Decision Date2019-12-10
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Health Line CT CVC 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 2019-12-10 under 510(k) number K192533. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Health Line CT CVC?

Health Line CT CVC is a medical device that received FDA 510(k) clearance on 2019-12-10. The listed applicant is Health Line International Corporation. The 510(k) number is K192533.

When did Health Line CT CVC receive FDA 510(k) clearance?

Health Line CT CVC received FDA 510(k) clearance on 2019-12-10, under 510(k) number K192533.

Who is the listed applicant for Health Line CT CVC?

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 Health Line CT CVC?

The FDA product code for Health Line CT CVC is FOZ.

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 CatheterK160448ARTLINE

Related Devices (Code: FOZ)

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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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