Cleared Traditional

PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER

K962695 · Sims Deltec, Inc. · General Hospital
Oct 1996
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K962695 is an FDA 510(k) clearance for the PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE 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 October 1, 1996, 82 days after receiving the submission on July 11, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K962695 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 1996
Decision Date October 01, 1996
Days to Decision 82 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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