Cleared Traditional

CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH

K926139 · Bard Access Systems, Inc. · General Hospital
Jan 1995
Decision
757d
Days
Class 2
Risk

About This 510(k) Submission

K926139 is an FDA 510(k) clearance for the CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH, a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II — Special Controls, product code LJT), submitted by Bard Access Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 3, 1995, 757 days after receiving the submission on December 7, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K926139 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 1992
Decision Date January 03, 1995
Days to Decision 757 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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