Cleared Traditional

MEDRAD CONTRAST HOLDER

K964782 · Medrad, Inc. · General Hospital
Feb 1997
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K964782 is an FDA 510(k) clearance for the MEDRAD CONTRAST HOLDER, a Stand, Infusion (Class I — General Controls, product code FOX), submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on February 25, 1997, 90 days after receiving the submission on November 27, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6990.

Submission Details

510(k) Number K964782 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 1996
Decision Date February 25, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FOX — Stand, Infusion
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6990

More from Medrad, Inc.

View all
JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6
K133023 · MCW · Aug 2014
ANGIOJET ULTRA POWER PULSE KIT
K130381 · QEW · Jul 2013
JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM
K130637 · MCW · Apr 2013
JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM
K122916 · MCW · Oct 2012
ANGIOJET SOLENT DISTA THROMBECTOMY SET
K113363 · QEZ · Jun 2012