Cleared Special

PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR

K024156 · Oscor, Inc. · Cardiovascular

Jan 2003

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K024156 is an FDA 510(k) clearance for the PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR, a Pacemaker Lead Adaptor (Class II — Special Controls, product code DTD), submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on January 14, 2003, 28 days after receiving the submission on December 17, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3620.

Submission Details

510(k) Number	K024156 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 2002
Decision Date	January 14, 2003
Days to Decision	28 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Statement