Cleared Special

INTRAVSCULAR ADMINISTRATION SET

K100946 · Terumo Europe N.V. · General Hospital
Aug 2010
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K100946 is an FDA 510(k) clearance for the INTRAVSCULAR ADMINISTRATION SET, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on August 2, 2010, 118 days after receiving the submission on April 6, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K100946 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 2010
Decision Date August 02, 2010
Days to Decision 118 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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