Cleared Traditional

INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,

K103551 · Baxter Healthcare Corp · General Hospital
Mar 2011
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K103551 is an FDA 510(k) clearance for the INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,, 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 March 25, 2011, 113 days after receiving the submission on December 2, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K103551 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2010
Decision Date March 25, 2011
Days to Decision 113 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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