Cleared Traditional

KENSEY CATHETER (K880194) - FDA 510(k) Clearance

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

K880194 · Theratek, Inc. · Cardiovascular device
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Apr 1988
Decision
90d
Days
Class 2
Risk

K880194 is an FDA 510(k) clearance for the KENSEY CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Theratek, Inc. (Miami, US). The FDA issued a Cleared decision on April 18, 1988 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Theratek, Inc. devices

Submission Details

510(k) Number K880194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1988
Decision Date April 18, 1988
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 155
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K880194.
STANDARD, TUOHY BORST & DUAL VALVE Y-CONNECTOR
K885247 · Baxter Healthcare Corp · Mar 1989
OMEGA NV(TM) BALLOON DILATATION CATHETER
K882052 · Cook, Inc. · Sep 1988
CORDIS PTA DILATATION CATHETERS
K880612 · Cordis Corp. · Jul 1988
DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY)
K870215 · Cook, Inc. · Aug 1987
SCHNEIDER-SHILEY SELDINGER INITIAL PUNCTURE INSTR
K862467 · Shiley, Inc. · Aug 1986
SCHNEIDER-SHILEY PERIPHERAL DILATATION CATHETER
K854319 · Shiley, Inc. · Mar 1986