Cleared Traditional

CATHETER INSERTION TRAY

K962849 · Medcare Medical Group, Inc. · General Hospital
Oct 1996
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K962849 is an FDA 510(k) clearance for the CATHETER INSERTION TRAY, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Medcare Medical Group, Inc. (East Swanzey, US). The FDA issued a Cleared decision on October 7, 1996, 77 days after receiving the submission on July 22, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K962849 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1996
Decision Date October 07, 1996
Days to Decision 77 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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