Cleared Traditional

TRAC-WRIGHT TRAC 10 CATHETER (K915238) - FDA 510(k) Clearance

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

K915238 · Dow Corning Wright · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
90d
Days
Class 2
Risk

K915238 is an FDA 510(k) clearance for the TRAC-WRIGHT TRAC 10 CATHETER. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Dow Corning Wright (Miami Lakes, US). The FDA issued a Cleared decision on February 19, 1992 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 870.4875 - 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. 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 Dow Corning Wright devices

Submission Details

510(k) Number K915238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1991
Decision Date February 19, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
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 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 40
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K915238.
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS
K121774 · Boston Scientific Corp · Sep 2012
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