Cleared Traditional

K891588 - TRI-LUMEN INTRA VASCULAR BALLOON CATHET...

K891588 is the FDA 510(k) clearance for TRI-LUMEN INTRA VASCULAR BALLOON CATHET... by Ideal Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code LQR) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K891588 · Ideal Medical, Inc. · Gastroenterology & Urology device
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Sep 1989
Decision
195d
Days
Class 2
Risk

K891588 is an FDA 510(k) clearance for the TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE). Classified as Dislodger, Stone, Biliary (product code LQR), Class II - Special Controls.

Submitted by Ideal Medical, Inc. (Clearwater, US). The FDA issued a Cleared decision on September 28, 1989 after a review of 195 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ideal Medical, Inc. devices

Submission Details

510(k) Number K891588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1989
Decision Date September 28, 1989
Days to Decision 195 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 130d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LQR Dislodger, Stone, Biliary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 Gastroenterology & Urology devices follow this clearance model.