Cleared Traditional

K863936 - DUFFY BOLUS INJECTOR
(FDA 510(k) Clearance)

K863936 · Viox Corp. · Radiology device

Jan 1987

Decision

89d

Days

Class 1

Risk

K863936 is an FDA 510(k) clearance for the DUFFY BOLUS INJECTOR. This device is classified as a Holder, Syringe, Lead (Class I - General Controls, product code IWR).

Submitted by Viox Corp. (Seattle, US). The FDA issued a Cleared decision on January 6, 1987, 89 days after receiving the submission on October 9, 1986.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.6500.

Submission Details

510(k) Number	K863936 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 09, 1986
Decision Date	January 06, 1987
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—