Cleared Special

INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S

K123874 · Baxter Healthcare Corp · General Hospital
Jan 2013
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K123874 is an FDA 510(k) clearance for the INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S, 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 10, 2013, 24 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 K123874 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2012
Decision Date January 10, 2013
Days to Decision 24 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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