Cleared Special

Health Line CT Midline Catheter

K200263 · Health Line International Corporation · General Hospital

Mar 2020

Decision

38d

Days

Class 2

Risk

About This 510(k) Submission

K200263 is an FDA 510(k) clearance for the Health Line CT Midline Catheter, 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 March 12, 2020, 38 days after receiving the submission on February 3, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K200263 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 2020
Decision Date	March 12, 2020
Days to Decision	38 days
Submission Type	Special
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