Cleared Special

K170403 - CenterCross Ultra LV Catheter

K170403 is an FDA 510(k) clearance for CenterCross Ultra LV Catheter, manufactured by Roxwood Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 26-day FDA review.

K170403 · Roxwood Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
26d
Days
Class 2
Risk

K170403 is an FDA 510(k) clearance for the CenterCross Ultra LV Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Roxwood Medical, Inc. (Redwood City, US). The FDA issued a Cleared decision on March 7, 2017 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Roxwood Medical, Inc. devices

FDA 510(k) Submission Details - K170403

510(k) Number K170403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2017
Decision Date March 07, 2017
Days to Decision 26 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
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 651
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K170403.
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K162563 · Codman & Shurtleff, Inc. · Jan 2017