Cleared Traditional

3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH

K926331 · Bard Access Systems, Inc. · General Hospital
Mar 1994
Decision
446d
Days
Class 2
Risk

About This 510(k) Submission

K926331 is an FDA 510(k) clearance for the 3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH, 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 March 7, 1994, 446 days after receiving the submission on December 16, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K926331 FDA.gov
FDA Decision Cleared SEKD
Date Received December 16, 1992
Decision Date March 07, 1994
Days to Decision 446 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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