Cleared Traditional

K893411 - STEALTH DILATION CATHETER SYSTEM

K893411 is an FDA 510(k) clearance for STEALTH DILATION CATHETER SYSTEM, manufactured by Target Therapeutics. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K893411 · Target Therapeutics · Cardiovascular device
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Sep 1989
Decision
126d
Days
Class 2
Risk

K893411 is an FDA 510(k) clearance for the STEALTH DILATION CATHETER SYSTEM. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Target Therapeutics (San Jose, US). The FDA issued a Cleared decision on September 5, 1989 after a review of 126 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 Target Therapeutics devices

FDA 510(k) Submission Details - K893411

510(k) Number K893411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1989
Decision Date September 05, 1989
Days to Decision 126 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 125d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

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 348
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K893411.
ACCESSOR PERIPHERAL DILATING GUIDE WIRE
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BALLOON DILATATION CATHETER
K894944 · Peripheral Systems Group · Jan 1990
USCI PTA BALLOON DILATATION CATHETER
K890405 · C.R. Bard, Inc. · Aug 1989
ROTATING HEMOSTATIC VALVE
K890800 · Datascope Corp. · Jun 1989
USCI DISP. Y-CONNECTOR W/MODIFIED TUOHY-BORST ADAP
K890325 · C.R. Bard, Inc. · Mar 1989