Cleared Traditional

K973403 - CARDIOSMART ST (FDA 510(k) Clearance)

K973403 · Marquette Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
184d
Days
-
Risk

K973403 is an FDA 510(k) clearance for the CARDIOSMART ST.

Submitted by Marquette Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on March 12, 1998 after a review of 184 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Marquette Medical Systems, Inc. devices

Submission Details

510(k) Number K973403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1997
Decision Date March 12, 1998
Days to Decision 184 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
59d slower than avg
Panel avg: 125d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -