Cleared Traditional

K880231 - MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER

K880231 is an FDA 510(k) clearance for MODIFIED PRUITT IRRIGATION & OCCLUSION ..., manufactured by Ideas For Medicine, Inc.. The device is a Class 2 Cardiovascular device with product code DQT cleared through the Traditional 510(k) pathway after a 133-day FDA review.

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

FDA 510(k) Submission Details - K880231

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.

DQT Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DQT Occluder, Catheter Tip

Devices cleared under the same product code (DQT) and FDA review panel - the closest regulatory comparables to K880231.
GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
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