Cleared Traditional

FOGARTY OCCLUDER PAD (K831809) - FDA 510(k) Clearance

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

K831809 · Thomas J. Fogarty, M.D. · Cardiovascular device
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Aug 1984
Decision
448d
Days
Class 2
Risk

K831809 is an FDA 510(k) clearance for the FOGARTY OCCLUDER PAD. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Thomas J. Fogarty, M.D. (Walker, US). The FDA issued a Cleared decision on August 27, 1984 after a review of 448 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Thomas J. Fogarty, M.D. devices

Submission Details

510(k) Number K831809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1983
Decision Date August 27, 1984
Days to Decision 448 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
323d slower than avg
Panel avg: 125d · This submission: 448d
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 203
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