Cleared Traditional

K211738 - Rotarex Atherectomy System

K211738 is an FDA 510(k) clearance for Rotarex Atherectomy System, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K211738 · C.R. Bard, Inc. · Cardiovascular device
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Sep 2021
Decision
99d
Days
Class 2
Risk

K211738 is an FDA 510(k) clearance for the Rotarex Atherectomy System. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on September 14, 2021 after a review of 99 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K211738

510(k) Number K211738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2021
Decision Date September 14, 2021
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
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 119
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K211738.
Revolution Peripheral Atherectomy System
K212351 · Rex Medical, L.P. · Dec 2021
Pantheris System
K212047 · Avinger, Inc. · Nov 2021
Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system
K210586 · Cardiovascular Systems, Inc. · Sep 2021
TurboHawk Plus Directional Atherectomy System
K212027 · Medtronic, Inc. · Aug 2021
2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System
K211518 · Volcano Atheromed, Inc. · Jun 2021
Auryon Atherectomy System
K202835 · Eximo Medical, Ltd. · Dec 2020