Cleared Traditional

INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326

K060074 · Baxter Healthcare Corp · General Hospital
Mar 2006
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K060074 is an FDA 510(k) clearance for the INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326, 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 29, 2006, 78 days after receiving the submission on January 10, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K060074 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2006
Decision Date March 29, 2006
Days to Decision 78 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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