Cleared Special

INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET

K123868 · Baxter Healthcare Corp · General Hospital
Jan 2013
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K123868 is an FDA 510(k) clearance for the INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on January 8, 2013, 22 days after receiving the submission on December 17, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K123868 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2012
Decision Date January 08, 2013
Days to Decision 22 days
Submission Type Special
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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