Cleared Traditional

K860584 - SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN
(FDA 510(k) Clearance)

K860584 · Cardiac Pacemakers, Inc. · Cardiovascular

Jun 1986

Decision

108d

Days

Class 3

Risk

K860584 is an FDA 510(k) clearance for the SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN, 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 June 6, 1986, 108 days after receiving the submission on February 18, 1986. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3700.

Submission Details

510(k) Number	K860584 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 18, 1986
Decision Date	June 06, 1986
Days to Decision	108 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—