Cleared Traditional

Cook Unimpregnated Central Venous Catheter

K182252 · Cook Incorporated · General Hospital

May 2019

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K182252 is an FDA 510(k) clearance for the Cook Unimpregnated Central Venous Catheter, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on May 17, 2019, 270 days after receiving the submission on August 20, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K182252 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 2018
Decision Date	May 17, 2019
Days to Decision	270 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