Cleared Abbreviated

K041630 - ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS

K041630 is an FDA 510(k) clearance for ORBITAL ATHERECTOMY SYSTEM FOR TREATMEN..., manufactured by Cardiovascular Systems Incorporated. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Abbreviated 510(k) pathway after a 229-day FDA review.

K041630 · Cardiovascular Systems Incorporated · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
229d
Days
Class 2
Risk

K041630 is an FDA 510(k) clearance for the ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Cardiovascular Systems Incorporated (Stoughton, US). The FDA issued a Cleared decision on January 31, 2005 after a review of 229 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K041630

510(k) Number K041630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2004
Decision Date January 31, 2005
Days to Decision 229 days
Submission Type Abbreviated
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
104d slower than avg
Panel avg: 125d · This submission: 229d
Pathway characteristics
Standards-based clearance path.

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 142
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K041630.
THROMCAT THROMBECTOMY CATHETER SYSTEM
K060016 · Kensey Nash Corp. · Apr 2006
MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300,
K053460 · Fox Hollow Technologies · Jan 2006
SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300
K043553 · Fox Hollow Technologies · Feb 2005
X-SIZER CATHETER SYSTEM
K021096 · Ev3 Corporation · Sep 2004
CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT
K040252 · Rex Medical · Feb 2004
SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110
K033997 · Bacchus Vascular, Inc. · Feb 2004
K041630 · ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
Download PDF FDA Summary Cardiovascular System…