Cleared Special

DUAL LUER LOCK CAP, MODEL 2C6250

K101385 · Baxter Healthcare Corp · General Hospital
Jun 2010
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K101385 is an FDA 510(k) clearance for the DUAL LUER LOCK CAP, MODEL 2C6250, 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 June 22, 2010, 35 days after receiving the submission on May 18, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K101385 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2010
Decision Date June 22, 2010
Days to Decision 35 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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