Cleared Abbreviated

DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES

K063114 · Coeur, Inc. · General Hospital
Feb 2007
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K063114 is an FDA 510(k) clearance for the DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES, a Tubing, Fluid Delivery (Class II — Special Controls, product code FPK), submitted by Coeur, Inc. (Lebanon, US). The FDA issued a Cleared decision on February 9, 2007, 121 days after receiving the submission on October 11, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K063114 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 2006
Decision Date February 09, 2007
Days to Decision 121 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPK — Tubing, Fluid Delivery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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