Cleared Traditional

K913397 - MEGA ANGIOGRAM KIT

K913397 is an FDA 510(k) clearance for MEGA ANGIOGRAM KIT, manufactured by Mega Medical, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K913397

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.

DQO Device Classification - Class 2, Special Controls

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 410
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K913397.
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ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION
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CORDIS DUAL LUMEN PRESSURE MONITORING CATHETER
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ACS RX SUPPORT CATHETER
K911957 · Advanced Cardiovascular Systems, Inc. · Sep 1991