Cleared Traditional

EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE

K974013 · Sims Deltec, Inc. · General Hospital
Dec 1997
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K974013 is an FDA 510(k) clearance for the EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE, 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 December 17, 1997, 56 days after receiving the submission on October 22, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K974013 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 1997
Decision Date December 17, 1997
Days to Decision 56 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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