Cleared Traditional

NEXUS MIDLINE CT CATHETER

K140270 · Health Line International Corporation · General Hospital

Aug 2014

Decision

198d

Days

Class 2

Risk

About This 510(k) Submission

K140270 is an FDA 510(k) clearance for the NEXUS MIDLINE CT CATHETER, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Health Line International Corporation (St. George, US). The FDA issued a Cleared decision on August 20, 2014, 198 days after receiving the submission on February 3, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K140270 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 2014
Decision Date	August 20, 2014
Days to Decision	198 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