Cleared Traditional

SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER (K902091) - FDA 510(k) Clearance

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

K902091 · Schneider Intl., Ltd. · Cardiovascular device
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Sep 1990
Decision
140d
Days
Class 2
Risk

K902091 is an FDA 510(k) clearance for the SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Schneider Intl., Ltd. (Plymouth, US). The FDA issued a Cleared decision on September 26, 1990 after a review of 140 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 Schneider Intl., Ltd. devices

Submission Details

510(k) Number K902091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1990
Decision Date September 26, 1990
Days to Decision 140 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 125d · This submission: 140d
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 152
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K902091.
ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER
K900677 · Cook, Inc. · Feb 1991
PE-MT 5 MEDI-TECH BALLOON DILATATION CATHETER
K900094 · Boston Scientific Corp · Oct 1990
MEDI-TECH DILATATION CATHETERS ULTRA THIN II
K897106 · Boston Scientific Corp · Oct 1990
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