Cleared Special

K160389 - NovaCross Microcatheter

K160389 is the FDA 510(k) clearance for NovaCross Microcatheter by Nitiloop , Ltd.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Special 510(k) pathway after a 29-day FDA review.

K160389 · Nitiloop , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
29d
Days
Class 2
Risk

K160389 is an FDA 510(k) clearance for the NovaCross Microcatheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Nitiloop , Ltd. (Netanya, IL). The FDA issued a Cleared decision on March 11, 2016 after a review of 29 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 Nitiloop , Ltd. devices

Submission Details

510(k) Number K160389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2016
Decision Date March 11, 2016
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 574
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K160389.
YOGA Microcatheter
K162563 · Codman & Shurtleff, Inc. · Jan 2017
ASAHI Corsair Pro
K161126 · Asahi Intecc Co., Ltd. · Aug 2016
ASAHI Corsair Armet
K161362 · Asahi Intecc Co., Ltd. · Jun 2016
ASAHI Corsair Armet
K152249 · Asahi Intecc Co., Ltd. · Mar 2016
ASAHI Caravel
K152447 · Asahi Intecc Co., Ltd. · Jan 2016
Stingray LP Catheter
K152401 · Boston Scientific Corporation · Dec 2015