Cleared Traditional

K974087 - MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT

K974087 · Hewlett-Packard Co. · Cardiovascular device
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Jun 1998
Decision
229d
Days
-
Risk

K974087 is an FDA 510(k) clearance for the MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT.

Submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on June 15, 1998 after a review of 229 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.

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FDA 510(k) Submission Details - K974087

510(k) Number K974087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1997
Decision Date June 15, 1998
Days to Decision 229 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
104d slower than avg
Panel avg: 125d · This submission: 229d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

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