Cleared Traditional

K120834 - CORPATH 200 SYSTEM

K120834 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 122-day FDA review.

K120834 · Corindus, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
122d
Days
Class 2
Risk

K120834 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. (Baltimore, US). The FDA issued a Cleared decision on July 19, 2012 after a review of 122 days - within the typical 510(k) review window.

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 - K120834

510(k) Number K120834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2012
Decision Date July 19, 2012
Days to Decision 122 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
3d faster than avg
Panel avg: 125d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01076036 Completed Interventional Industry-sponsored

CorPath™ 200: Robotically-Assisted Percutaneous Coronary Intervention (PCI)

CorPath™ 200 System: Coronary Remote Catheterization Feasibility Study

8
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Coronary Artery Disease
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Juan F Granada, MD
Sponsor Siemens Healthineers Endovascular Robotics, Inc. (industry)
Started 2010-02-01 → Primary completion 2010-05-01
Primary outcome
Clinical Procedural Success
View full study on ClinicalTrials.gov

Regulatory Peers - DXX System, Catheter Control, Steerable

All 31
Devices cleared under the same product code (DXX) and FDA review panel - the closest regulatory comparables to K120834.
SENSEI X ROBOTIC CATHETER SYSTEM
K141822 · Hanson Medical, Inc. · Aug 2014
MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
K132369 · Hansen Medical, Inc. · Sep 2013
AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES
K122488 · Catheter Robotics, Inc. · Nov 2012
AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES
K113628 · Catheter Robotics, Inc. · Jun 2012
HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER
K111004 · Hansen Medical, Inc. · May 2012
SENSEI X ROBOTIC CATHETER SYSTEM
K102168 · Hansen Medical, Inc. · Oct 2010