Cleared Traditional

CADD ADMINISTRATION SET

K991599 · Sims Deltec, Inc. · General Hospital
Jun 1999
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K991599 is an FDA 510(k) clearance for the CADD ADMINISTRATION SET, 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 15, 1999, 36 days after receiving the submission on May 10, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K991599 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 1999
Decision Date June 15, 1999
Days to Decision 36 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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