Cleared Traditional

K894738 - MODEL 6888 LEAD TUNNELER
(FDA 510(k) Clearance)

K894738 · Cardiac Pacemakers, Inc. · Cardiovascular

Sep 1989

Decision

48d

Days

Class 1

Risk

K894738 is an FDA 510(k) clearance for the MODEL 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 September 13, 1989, 48 days after receiving the submission on July 27, 1989. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4500.

Submission Details

510(k) Number	K894738 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 27, 1989
Decision Date	September 13, 1989
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—