Cleared Traditional

K963925 - THROMBOLYTIC BRUSH CATHETER

K963925 is the FDA 510(k) clearance for THROMBOLYTIC BRUSH CATHETER by Micro Therapeutics, Inc.. It is a Class 2 Cardiovascular device (product code MCW) cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K963925 · Micro Therapeutics, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 1997
Decision
312d
Days
Class 2
Risk

K963925 is an FDA 510(k) clearance for the THROMBOLYTIC BRUSH CATHETER. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. (San Clemente, US). The FDA issued a Cleared decision on August 8, 1997 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - 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. Elevated predicate reliance profile. 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 Micro Therapeutics, Inc. devices

Submission Details

510(k) Number K963925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1996
Decision Date August 08, 1997
Days to Decision 312 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
187d slower than avg
Panel avg: 125d · This submission: 312d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MCW Catheter, Peripheral, Atherectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
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 - MCW Catheter, Peripheral, Atherectomy

All 48
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K963925.
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65
K990829 · Arrow Intl., Inc. · May 1999
OASIS THROMBECTOMY CATHETER SYSTEM
K982363 · Boston Scientific Corp · Feb 1999
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
K970296 · Boston Scientific Corp · Aug 1997
ARROW-TREROTOLA PTD CATHETER
K970080 · Arrow Intl., Inc. · Jul 1997
TRAC-WRIGHT TRAC 10 CATHETER
K915238 · Dow Corning Wright · Feb 1992
THERATEK GROUP EXCHANGE CATHETER
K904680 · Dow Corning Wright · Dec 1990