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
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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
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 125d · This submission: 122d
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
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