Cleared Traditional

CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1

K991301 · Sims Deltec, Inc. · General Hospital
Jun 1999
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K991301 is an FDA 510(k) clearance for the CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1, 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, 54 days after receiving the submission on April 16, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K991301 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 1999
Decision Date June 09, 1999
Days to Decision 54 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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