Cleared Special

LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO

K130245 · Baxter Healthcare Corp · General Hospital
Mar 2013
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K130245 is an FDA 510(k) clearance for the LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO, a Stopcock, I.v. Set (Class II — Special Controls, product code FMG), submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on March 1, 2013, 29 days after receiving the submission on January 31, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K130245 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2013
Decision Date March 01, 2013
Days to Decision 29 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMG — Stopcock, I.v. Set
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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