Cleared Traditional

Health Line CT CVC

K192533 · Health Line International Corporation · General Hospital

Dec 2019

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K192533 is an FDA 510(k) clearance for the Health Line CT CVC, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Health Line International Corporation (Salt Lake City, US). The FDA issued a Cleared decision on December 10, 2019, 85 days after receiving the submission on September 16, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K192533 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 2019
Decision Date	December 10, 2019
Days to Decision	85 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200