Cleared Traditional

K914985 - DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION
(FDA 510(k) Clearance)

K914985 · E-Z-Em, Inc. · Cardiovascular

Dec 1991

Decision

58d

Days

Class 2

Risk

K914985 is an FDA 510(k) clearance for the DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION, a Trocar (Class II — Special Controls, product code DRC), submitted by E-Z-Em, Inc. (Glens Falls, US). The FDA issued a Cleared decision on December 20, 1991, 58 days after receiving the submission on October 23, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1390.

Submission Details

510(k) Number	K914985 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 23, 1991
Decision Date	December 20, 1991
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement