Cleared Traditional

VASCULAR ACCESS CATHETER ACCESSORIES

K935380 · Bard Access Systems, Inc. · General Hospital
Feb 1995
Decision
466d
Days
Class 2
Risk

About This 510(k) Submission

K935380 is an FDA 510(k) clearance for the VASCULAR ACCESS CATHETER ACCESSORIES, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Bard Access Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 17, 1995, 466 days after receiving the submission on November 8, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K935380 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 1993
Decision Date February 17, 1995
Days to Decision 466 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5970

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