Cleared Traditional

K973403 - CARDIOSMART ST

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

FDA 510(k) Submission Details - K973403

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 125d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 54
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K973403.
MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT
K974087 · Hewlett-Packard Co. · Jun 1998
ARCHIMED 4210 AND 4220
K973922 · Biosound Esaote, Inc. · May 1998
MUSE CARDIOVASCULAR INFORMATION SYSTEM
K980495 · Marquette Medical Systems, Inc. · May 1998
ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION
K974199 · Marquette Medical Systems, Inc. · Feb 1998
FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH
K971440 · Fukuda Denshi USA, Inc. · Dec 1997
CARDIOVIT CS-200
K970879 · Schiller America, Inc. · Jun 1997