Cleared Traditional

MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER (K880231) - FDA 510(k) Clearance

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

K880231 · Ideas For Medicine, Inc. · Cardiovascular device
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May 1988
Decision
133d
Days
Class 2
Risk

K880231 is an FDA 510(k) clearance for the MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER. Classified as Occluder, Catheter Tip (product code DQT), Class II - Special Controls.

Submitted by Ideas For Medicine, Inc. (Clearwater, US). The FDA issued a Cleared decision on May 25, 1988 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1370 - 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 Ideas For Medicine, Inc. devices

Submission Details

510(k) Number K880231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1988
Decision Date May 25, 1988
Days to Decision 133 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 125d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQT Occluder, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1370
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.