Cleared Traditional

K863045 - PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580
(FDA 510(k) Clearance)

K863045 · Cardiac Pacemakers, Inc. · Cardiovascular

Sep 1986

Decision

48d

Days

Class 3

Risk

K863045 is an FDA 510(k) clearance for the PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580, a Programmer, Pacemaker (Class III — Premarket Approval, product code KRG), submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 29, 1986, 48 days after receiving the submission on August 12, 1986. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3700.

Submission Details

510(k) Number	K863045 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 1986
Decision Date	September 29, 1986
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—