FDA 510(k)

ORION II CT CVC

K-Number: K113622 · 2012-05-18

ApplicantHealth Line International Corporation (Hlic)

Decision Date2012-05-18

Product CodeFOZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ORION II CT CVC is the device name listed in this FDA 510(k) record. The listed applicant is Health Line International Corporation (Hlic). It received FDA 510(k) clearance on 2012-05-18 under 510(k) number K113622. 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 ORION II CT CVC?

ORION II CT CVC is a medical device that received FDA 510(k) clearance on 2012-05-18. The listed applicant is Health Line International Corporation (Hlic). The 510(k) number is K113622.

When did ORION II CT CVC receive FDA 510(k) clearance?

ORION II CT CVC received FDA 510(k) clearance on 2012-05-18, under 510(k) number K113622.

Who is the listed applicant for ORION II CT CVC?

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

What is the FDA product code for ORION II CT CVC?

The FDA product code for ORION II CT CVC is FOZ.

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Other records listing Health Line International Corporation (Hlic) as applicant

K070630HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE

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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.