Cleared Traditional

ASTRA 2,3,4 AND 6: CHIP REVISION (K863000) - FDA 510(k) Clearance

K863000 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Aug 1986
Decision
11d
Days
-
Risk

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 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K863000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1986
Decision Date August 19, 1986
Days to Decision 11 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 125d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -