Cleared Traditional

PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM

K994216 · Sims Deltec, Inc. · General Hospital
Jan 2000
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K994216 is an FDA 510(k) clearance for the PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM, a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II — Special Controls, product code LJT), submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 27, 2000, 43 days after receiving the submission on December 15, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K994216 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 1999
Decision Date January 27, 2000
Days to Decision 43 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5965

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