Cleared Traditional

PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS

K961580 · Sims Deltec, Inc. · General Hospital
Sep 1996
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K961580 is an FDA 510(k) clearance for the PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS, 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 September 20, 1996, 149 days after receiving the submission on April 24, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K961580 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 1996
Decision Date September 20, 1996
Days to Decision 149 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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