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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 125d · This submission: 157d
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.

Regulatory Consultant

Cardiomed Device Consultants
Mona Advani

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02371785 Completed Interventional Industry-sponsored

Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease

20
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Peripheral Arterial Disease
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Marianne Brodmann, M.D.
Sponsor Siemens Healthineers Endovascular Robotics, Inc. (industry)
Started 2015-02-03 → Primary completion 2015-04-28 → Completed 2015-05-22
Primary outcome
Device Technical Success
Secondary 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 K152999.
CorPath GRX System
K173806 · Corindus, Inc. · Mar 2018
CorPath GRX System
K173288 · Corindus, Inc. · Feb 2018
CorPath GRX System
K160121 · Corindus, Inc. · Oct 2016
CorPath 200 System
K150892 · Corindus, Inc. · Oct 2015
Magellan Robotic System
K151730 · Hansen Medical, Inc. · Jul 2015
Magellan Robotic System, Magellan Robotic Catheter 10Fr
K143227 · Hansen Medical, Inc. · Jul 2015