Cleared Traditional

K013473 - XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X

Also marketed or referenced as:
XTD CONTROL CONSOLE, MODEL # CT0006001 XTD COLLECTION BOTTLE, MODEL

K013473 is an FDA 510(k) clearance for XTD THROMBECTOMY CATHETER, manufactured by Xtrak Medical, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K013473 · Xtrak Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
139d
Days
Class 2
Risk

K013473 is an FDA 510(k) clearance for the XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Xtrak Medical, Inc. (Hopkonton, US). The FDA issued a Cleared decision on March 6, 2002 after a review of 139 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.

FDA 510(k) Submission Details - K013473

510(k) Number K013473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2001
Decision Date March 06, 2002
Days to Decision 139 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 125d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MCW Device Classification - Class 2, Special Controls

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 145
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K013473.
REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200
K024243 · Fox Hollow Technologies · Jun 2003
REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM
K031610 · Rex Medical · May 2003
SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM
K022640 · Bacchus Vascular, Inc. · Dec 2002
BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755
K003570 · Bacchus Vascular, Inc. · Jun 2001
BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD
K993816 · Baxter Edwards · May 2000
POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002
K993564 · Possis Medical, Inc. · Apr 2000
K013473 · XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X
Download PDF FDA Summary Xtrak Medical, Inc.