Cleared Traditional

V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE

K081289 · Baxter Healthcare Corp · General Hospital
Aug 2008
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K081289 is an FDA 510(k) clearance for the V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE, 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 August 4, 2008, 89 days after receiving the submission on May 7, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K081289 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2008
Decision Date August 04, 2008
Days to Decision 89 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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