Cleared Traditional

K896403 - MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM

K896403 is an FDA 510(k) clearance for MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM, manufactured by Intensive Technology, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K896403 · Intensive Technology, Inc. · Cardiovascular device
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Mar 1990
Decision
119d
Days
Class 2
Risk

K896403 is an FDA 510(k) clearance for the MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Intensive Technology, Inc. (San Diego, US). The FDA issued a Cleared decision on March 6, 1990 after a review of 119 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 Intensive Technology, Inc. devices

FDA 510(k) Submission Details - K896403

510(k) Number K896403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1989
Decision Date March 06, 1990
Days to Decision 119 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 125d · This submission: 119d
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 354
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K896403.
SMALL VESSEL BALLOON DILATATION CATHETER
K897124 · Boston Scientific Corp · Jul 1990
MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS
K901018 · Boston Scientific Corp · May 1990
LE PTA CATHETER
K894250 · Baxter Healthcare Corp · Mar 1990
ACCESSOR PERIPHERAL DILATING GUIDE WIRE
K895179 · Peripheral Systems Group · Feb 1990
EXPANSION OF THE CORDIS PTA DILATATION CATHETER
K894899 · Cordis Corp. · Jan 1990
BALLOON DILATATION CATHETER
K894944 · Peripheral Systems Group · Jan 1990