Cleared Traditional

CENTRA HEART STATION (K935589) - FDA 510(k) Clearance

K935589 · Marquette Electronics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
644d
Days
-
Risk

K935589 is an FDA 510(k) clearance for the CENTRA HEART STATION.

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on August 24, 1995 after a review of 644 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Marquette Electronics, Inc. devices

Submission Details

510(k) Number K935589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1993
Decision Date August 24, 1995
Days to Decision 644 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
519d slower than avg
Panel avg: 125d · This submission: 644d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 15
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K922394 · Nihon Kohden America, Inc. · Mar 1994