Cleared Traditional

STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014

K051370 · Baxter Healthcare Corp · General Hospital
Aug 2005
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K051370 is an FDA 510(k) clearance for the STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014, a Catheter And Tip, Suction (Class II — Special Controls, product code JOL), submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on August 12, 2005, 78 days after receiving the submission on May 26, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K051370 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2005
Decision Date August 12, 2005
Days to Decision 78 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code JOL — Catheter And Tip, Suction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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