Cleared Traditional

K942191 - URESIL DILATOR
(FDA 510(k) Clearance)

K942191 · Uresil Corp. · Cardiovascular device

Sep 1994

Decision

140d

Days

Class 2

Risk

K942191 is an FDA 510(k) clearance for the URESIL DILATOR. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).

Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on September 21, 1994, 140 days after receiving the submission on May 4, 1994.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number	K942191 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 04, 1994
Decision Date	September 21, 1994
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement