Cleared Traditional

CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS

K984055 · Sims Deltec, Inc. · General Hospital
Jan 1999
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K984055 is an FDA 510(k) clearance for the CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 29, 1999, 77 days after receiving the submission on November 13, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K984055 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1998
Decision Date January 29, 1999
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5200

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