Cleared Special

K170460 - Sorin Connect (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K170460 · Sorin Group Deutschland GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
113d
Days
Class 2
Risk

K170460 is an FDA 510(k) clearance for the Sorin Connect. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Sorin Group Deutschland GmbH (Munich, DE). The FDA issued a Cleared decision on June 8, 2017 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2450 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sorin Group Deutschland GmbH devices

Submission Details

510(k) Number K170460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2017
Decision Date June 08, 2017
Days to Decision 113 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DXJ Display, Cathode-ray Tube, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2450
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.