Cleared Traditional

FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER

K093026 · Footprint Medical · Cardiovascular
Feb 2010
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K093026 is an FDA 510(k) clearance for the FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Footprint Medical (San Antonio, US). The FDA issued a Cleared decision on February 24, 2010, 148 days after receiving the submission on September 29, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K093026 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2009
Decision Date February 24, 2010
Days to Decision 148 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340