Cleared Traditional

K915225 - MEGACART

K915225 · Siemens Burdick, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
224d
Days
-
Risk

K915225 is an FDA 510(k) clearance for the MEGACART.

Submitted by Siemens Burdick, Inc. (Miltoon, US). The FDA issued a Cleared decision on July 1, 1992 after a review of 224 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 Siemens Burdick, Inc. devices

FDA 510(k) Submission Details - K915225

510(k) Number K915225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1991
Decision Date July 01, 1992
Days to Decision 224 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
99d slower than avg
Panel avg: 125d · This submission: 224d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

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