Cleared Traditional

K921669 - MARQUETTE SL SERIES TRANSPORT REMOTE AC...

K921669 · Marquette Electronics, Inc. · Cardiovascular device
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May 1993
Decision
394d
Days
-
Risk

K921669 is an FDA 510(k) clearance for the MARQUETTE SL SERIES TRANSPORT REMOTE ACQUISITION.

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on May 7, 1993 after a review of 394 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: Standard predicate-based submission. Elevated predicate reliance profile. 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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Submission Details

510(k) Number K921669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1992
Decision Date May 07, 1993
Days to Decision 394 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 125d · This submission: 394d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 43
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