Cleared Special

PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU

K040569 · Oscor, Inc. · Cardiovascular

Apr 2004

Decision

34d

Days

Class 3

Risk

About This 510(k) Submission

K040569 is an FDA 510(k) clearance for the PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on April 7, 2004, 34 days after receiving the submission on March 4, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number	K040569 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 2004
Decision Date	April 07, 2004
Days to Decision	34 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Statement