Cleared Traditional

CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD

K955550 · Intermedics, Inc. · Cardiovascular
Jun 1996
Decision
197d
Days
Class 3
Risk

About This 510(k) Submission

K955550 is an FDA 510(k) clearance for the CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Intermedics, Inc. (Angleton, US). The FDA issued a Cleared decision on June 19, 1996, 197 days after receiving the submission on December 5, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K955550 FDA.gov
FDA Decision Cleared ST
Date Received December 05, 1995
Decision Date June 19, 1996
Days to Decision 197 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DTB — Permanent Pacemaker Electrode
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 870.3680

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