Cleared Traditional

K211738 - Rotarex Atherectomy System

K211738 is the FDA 510(k) clearance for Rotarex Atherectomy System by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 52
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