Cleared Traditional

K913397 - MEGA ANGIOGRAM KIT

K913397 is the FDA 510(k) clearance for MEGA ANGIOGRAM KIT by Mega Medical, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K913397 · Mega Medical, Inc. · Cardiovascular device
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Oct 1991
Decision
93d
Days
Class 2
Risk

K913397 is an FDA 510(k) clearance for the MEGA ANGIOGRAM KIT. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Mega Medical, Inc. (Tampa, US). The FDA issued a Cleared decision on October 31, 1991 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. 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 Mega Medical, Inc. devices

Submission Details

510(k) Number K913397 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received July 30, 1991
Decision Date October 31, 1991
Days to Decision 93 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 125d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 234
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K913397.
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K911957 · Advanced Cardiovascular Systems, Inc. · Sep 1991