Cleared Traditional

ASTRA 2,3,4 AND 6: CHIP REVISION

K863000 · Cardiac Pacemakers, Inc. · Cardiovascular

Aug 1986

Decision

11d

Days

—

Risk

About This 510(k) Submission

K863000 is an FDA 510(k) clearance for the ASTRA 2,3,4 AND 6: CHIP REVISION, submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on August 19, 1986, 11 days after receiving the submission on August 8, 1986. This device falls under the Cardiovascular review panel.

Submission Details

510(k) Number	K863000 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 08, 1986
Decision Date	August 19, 1986
Days to Decision	11 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—