Cleared Traditional

ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH. (K903582) - FDA 510(k) Clearance

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

K903582 · Catheter Sciences Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1990
Decision
90d
Days
Class 2
Risk

K903582 is an FDA 510(k) clearance for the ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH.. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Catheter Sciences Co. (North Brunswick, US). The FDA issued a Cleared decision on November 6, 1990 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 Catheter Sciences Co. devices

Submission Details

510(k) Number K903582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1990
Decision Date November 06, 1990
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 K903582.
TEGWIRE (TM)
K911203 · Boston Scientific Corp · Apr 1991
OWENS CATHETER
K896520 · Boston Scientific Corp · Mar 1991
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