Cleared Traditional

K132682 - PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA

K132682 is an FDA 510(k) clearance for PHOENIX 5F TRACKING ATHERECTOMY CATHETER, manufactured by Atheromed, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K132682 · Atheromed, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
142d
Days
Class 2
Risk

K132682 is an FDA 510(k) clearance for the PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CAT.... Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Atheromed, Inc. (Menlo Park, US). The FDA issued a Cleared decision on January 17, 2014 after a review of 142 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 - K132682

510(k) Number K132682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2013
Decision Date January 17, 2014
Days to Decision 142 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
17d slower than avg
Panel avg: 125d · This submission: 142d
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 142
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K132682.
1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP
K140944 · Atheromed, Inc. · Aug 2014
TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
K140775 · Spectranetics Corporation · Jul 2014
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
K133999 · Cardiovascular Systems, Inc. · Feb 2014
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
K133566 · Boston Scientific Corp · Dec 2013
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
K133399 · Cardiovascular Systems Incorporated · Nov 2013
STEALTH 360 ORBITAL PAD SYSTEM
K131092 · Cardio Systems, Inc. · Jun 2013
K132682 · PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA
Download PDF FDA Summary Atheromed, Inc.