Cleared Traditional

K011790 - MICROCRUISER PLUS INTRODUCER SET
(FDA 510(k) Clearance)

K011790 · Medical Device Technologies, Inc. · Cardiovascular device

Sep 2001

Decision

89d

Days

Class 2

Risk

K011790 is an FDA 510(k) clearance for the MICROCRUISER PLUS INTRODUCER SET. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).

Submitted by Medical Device Technologies, Inc. (Gainesville, US). The FDA issued a Cleared decision on September 5, 2001, 89 days after receiving the submission on June 8, 2001.

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

Submission Details

510(k) Number	K011790 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 08, 2001
Decision Date	September 05, 2001
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF