Cleared Traditional

MS CLASSIQUE BALLOON CATHETER (K943298) - FDA 510(k) Clearance

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

K943298 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 1994
Decision
62d
Days
Class 2
Risk

K943298 is an FDA 510(k) clearance for the MS CLASSIQUE BALLOON CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on September 8, 1994 after a review of 62 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Meadox Medicals, Div. Boston Scientific Corp. devices

Submission Details

510(k) Number K943298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1994
Decision Date September 08, 1994
Days to Decision 62 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 125d · This submission: 62d
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 154
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K943298.
POWERFLEX(TM) 5F PTA BALLOON CATHETER
K946052 · Cordis Corp. · Mar 1995
BARD PERIPHERAL BALLOON DILATATION CATHETER
K942400 · C.R. Bard, Inc. · Nov 1994
CORDIS SAVVY PTA BALLOON CATHETER
K942094 · Cordis Corp. · Nov 1994
CORDIS OPTA 5(TM) PTA BALLOON CATHETER, MODIFICATION
K940868 · Cordis Corp. · Jul 1994
BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER
K930745 · B.Braun Medical, Inc. · May 1994
CORDIS OPTA 5(TM), MODIFICATION
K933236 · Cordis Corp. · Dec 1993