Cleared Special

CT Midline

K170770 · Medical Components, Inc. (dba MedComp) · General Hospital

Jul 2017

Decision

133d

Days

Class 2

Risk

About This 510(k) Submission

K170770 is an FDA 510(k) clearance for the CT Midline, a Midline Catheter (Class II — Special Controls, product code PND), submitted by Medical Components, Inc. (dba MedComp) (Harleysville, US). The FDA issued a Cleared decision on July 25, 2017, 133 days after receiving the submission on March 14, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K170770 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2017
Decision Date	July 25, 2017
Days to Decision	133 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	PND — Midline Catheter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200
Definition	The Catheter Is Inserted Into The Peripheral Vascular System For Infusion Of Fluids And Medications For Less Than 28 Days.