Cleared Traditional

CADD-TPN ADMINISTRATION SET, MODEL 21-7071

K991255 · Sims Deltec, Inc. · General Hospital
Jun 1999
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K991255 is an FDA 510(k) clearance for the CADD-TPN ADMINISTRATION SET, MODEL 21-7071, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on June 9, 1999, 57 days after receiving the submission on April 13, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K991255 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1999
Decision Date June 09, 1999
Days to Decision 57 days
Submission Type Traditional
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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