REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER— 510(k) K934727

Name: FDA 510(k) clearance K934727
Creator: U.S. Food and Drug Administration
Published: 1994-01-10

Substantially Equivalent

Cardiac Pacemakers, Inc.

FDA 510(k) clearance K934727 for REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER, Substantially Equivalent on 1994-01-10. Applicant: Cardiac Pacemakers, Inc.. Device class: 1.

Clearance details

Applicant: Cardiac Pacemakers, Inc.
Product code: Code DWS
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 1993-10-01
Decision date: 1994-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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