Cleared Traditional

K152999 - CorPath 200 System

K152999 is an FDA 510(k) clearance for CorPath 200 System, manufactured by Corindus, Inc.. The device is a Class 2 Cardiovascular device with product code DXX cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K152999 · Corindus, Inc. · Cardiovascular device
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Mar 2016
Decision
157d
Days
Class 2
Risk

K152999 is an FDA 510(k) clearance for the CorPath 200 System. Classified as System, Catheter Control, Steerable (product code DXX), Class II - Special Controls.

Submitted by Corindus, Inc. (Waltham, US). The FDA issued a Cleared decision on March 18, 2016 after a review of 157 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1290 - 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 Corindus, Inc. devices

FDA 510(k) Submission Details - K152999

510(k) Number K152999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2015
Decision Date March 18, 2016
Days to Decision 157 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 125d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXX Device Classification - Class 2, Special Controls

Product Code DXX System, Catheter Control, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1290
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 - DXX System, Catheter Control, Steerable

All 14
Devices cleared under the same product code (DXX) and FDA review panel - the closest regulatory comparables to K152999.
CorPath GRX System
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CorPath GRX System
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CorPath GRX System
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K150312 · Stereotaxis, Inc. · Jun 2015
VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS
K141530 · Stereotaxis, Inc. · Dec 2014
VDRIVE WITH V-LOOP/ VDRIVE DUO
K140804 · Stereotaxis, Inc. · Sep 2014