Cleared Traditional

K920936 - RMI EXTERNAL CORONARY ARTERY OCCLUDER (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K920936 · Research Medical, Inc. · Cardiovascular device
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Dec 1992
Decision
294d
Days
Class 2
Risk

K920936 is an FDA 510(k) clearance for the RMI EXTERNAL CORONARY ARTERY OCCLUDER. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Research Medical, Inc. (Midvale, US). The FDA issued a Cleared decision on December 18, 1992 after a review of 294 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Research Medical, Inc. devices

Submission Details

510(k) Number K920936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1992
Decision Date December 18, 1992
Days to Decision 294 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
169d slower than avg
Panel avg: 125d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - DXC Clamp, Vascular

All 201
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