Cleared Traditional

PLASTIC LOW PROFILE SUBCUTANEOUS PORT

K924250 · Bard Access Systems, Inc. · General Hospital
Oct 1993
Decision
406d
Days
Class 2
Risk

About This 510(k) Submission

K924250 is an FDA 510(k) clearance for the PLASTIC LOW PROFILE SUBCUTANEOUS PORT, 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 October 4, 1993, 406 days after receiving the submission on August 24, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K924250 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1992
Decision Date October 04, 1993
Days to Decision 406 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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