Cleared Traditional

K992880 - P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM
(FDA 510(k) Clearance)

K992880 · Sims Deltec, Inc. · General Hospital
Oct 1999
Decision
53d
Days
Class 2
Risk

K992880 is an FDA 510(k) clearance for the P.A.S. PORT ELITE 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 October 19, 1999, 53 days after receiving the submission on August 27, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K992880 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1999
Decision Date October 19, 1999
Days to Decision 53 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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