Cleared Traditional

MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD

K885240 · Tpl-Cordis, Inc. · Cardiovascular
Feb 1989
Decision
51d
Days
Class 3
Risk

About This 510(k) Submission

K885240 is an FDA 510(k) clearance for the MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Tpl-Cordis, Inc. (Englewood, US). The FDA issued a Cleared decision on February 10, 1989, 51 days after receiving the submission on December 21, 1988. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K885240 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1988
Decision Date February 10, 1989
Days to Decision 51 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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