Cleared Traditional

K915065 - I.V.IRRIGATION POLE
(FDA 510(k) Clearance)

K915065 · American Medical Mfg., Inc. · General Hospital

Feb 1992

Decision

95d

Days

Class 2

Risk

K915065 is an FDA 510(k) clearance for the I.V.IRRIGATION POLE, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by American Medical Mfg., Inc. (Calabasas, US). The FDA issued a Cleared decision on February 11, 1992, 95 days after receiving the submission on November 8, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K915065 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 08, 1991
Decision Date	February 11, 1992
Days to Decision	95 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200