Cleared Traditional

K111943 - AGILLS PF DELIVERY SYSTEM
(FDA 510(k) Clearance)

K111943 · St. Jude Medical, Cardiac Rhythm Management Divisi · Cardiovascular device

Sep 2011

Decision

83d

Days

Class 2

Risk

K111943 is an FDA 510(k) clearance for the AGILLS PF DELIVERY SYSTEM. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).

Submitted by St. Jude Medical, Cardiac Rhythm Management Divisi (Sylmar, US). The FDA issued a Cleared decision on September 29, 2011, 83 days after receiving the submission on July 8, 2011.

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

Submission Details

510(k) Number	K111943 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 08, 2011
Decision Date	September 29, 2011
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF