Cleared Traditional

CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED

K072576 · Baxter Healthcare Corp · General Hospital
Nov 2007
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K072576 is an FDA 510(k) clearance for the CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on November 6, 2007, 54 days after receiving the submission on September 13, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K072576 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2007
Decision Date November 06, 2007
Days to Decision 54 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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