Cleared Traditional

REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER

K934727 · Cardiac Pacemakers, Inc. · Cardiovascular
Jan 1994
Decision
101d
Days
Class 1
Risk

About This 510(k) Submission

K934727 is an FDA 510(k) clearance for the REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER, a Instruments, Surgical, Cardiovascular (Class I — General Controls, product code DWS), submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 10, 1994, 101 days after receiving the submission on October 1, 1993. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4500.

Submission Details

510(k) Number K934727 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 1993
Decision Date January 10, 1994
Days to Decision 101 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWS — Instruments, Surgical, Cardiovascular
Device Class Class I — General Controls
CFR Regulation 21 CFR 870.4500

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