Cleared Traditional

K024243 - REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200

Also marketed or referenced as:
REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406

K024243 is an FDA 510(k) clearance for REFORM PERIPHERAL CATHETER SYSTEM, manufactured by Fox Hollow Technologies. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K024243 · Fox Hollow Technologies · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
179d
Days
Class 2
Risk

K024243 is an FDA 510(k) clearance for the REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Fox Hollow Technologies (Redwood City, US). The FDA issued a Cleared decision on June 20, 2003 after a review of 179 days - an extended review cycle.

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 - K024243

510(k) Number K024243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2002
Decision Date June 20, 2003
Days to Decision 179 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
54d slower than avg
Panel avg: 125d · This submission: 179d
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 K024243.
SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110
K033997 · Bacchus Vascular, Inc. · Feb 2004
CLEANER II ROTATIONAL THROMBECTOMY SYSTEM
K033793 · Rex Medical · Dec 2003
AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060
K030504 · Idev Technologies, Inc. · Sep 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
XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X
K013473 · Xtrak Medical, Inc. · Mar 2002
K024243 · REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200
Download PDF FDA Summary Fox Hollow Technologi…