Cleared Traditional

PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER

K010426 · Sims Deltec, Inc. · General Hospital
Mar 2001
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K010426 is an FDA 510(k) clearance for the PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER, 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 March 8, 2001, 23 days after receiving the submission on February 13, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K010426 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2001
Decision Date March 08, 2001
Days to Decision 23 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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