Cleared Traditional

MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING (K953647) - FDA 510(k) Clearance

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

K953647 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular device
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May 1997
Decision
651d
Days
Class 2
Risk

K953647 is an FDA 510(k) clearance for the MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING. 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 May 16, 1997 after a review of 651 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

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

Submission Details

510(k) Number K953647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1995
Decision Date May 16, 1997
Days to Decision 651 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
526d slower than avg
Panel avg: 125d · This submission: 651d
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 K953647.
CORDIS OPTA 5 PTA BALLOON CATHETER
K971579 · Cordis Corp. · Jul 1997
CORDIS OPTA LP PTA BALLOON CATHETER
K971448 · Cordis Corp. · Jul 1997
PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS
K971010 · Cordis Corp. · Jun 1997
CORDIS OPTA5 PTA BALLOON CATHETER
K970620 · Cordis Corp. · May 1997
CHANNEL BALLOON CATHETER
K970379 · Boston Scientific Corp · May 1997
JUPITER PTA CATHETERS (VARIOUS)
K970299 · Cordis Corp. · Apr 1997