Cleared Traditional

K100798 - MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C
(FDA 510(k) Clearance)

K100798 · Medrad, Inc. · Radiology

Jun 2010

Decision

93d

Days

Class 2

Risk

K100798 is an FDA 510(k) clearance for the MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on June 23, 2010, 93 days after receiving the submission on March 22, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K100798 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2010
Decision Date	June 23, 2010
Days to Decision	93 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF