Cleared Traditional

K153141 - DyeVert Contrast Modulation System

K153141 is an FDA 510(k) clearance for DyeVert Contrast Modulation System, manufactured by Osprey Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K153141 · Osprey Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
97d
Days
Class 2
Risk

K153141 is an FDA 510(k) clearance for the DyeVert Contrast Modulation System. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Osprey Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on February 4, 2016 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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 Osprey Medical, Inc. devices

FDA 510(k) Submission Details - K153141

510(k) Number K153141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2015
Decision Date February 04, 2016
Days to Decision 97 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
28d faster than avg
Panel avg: 125d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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.

Clinical Evidence

ClinicalTrials.gov
NCT01976299 Completed Interventional Industry-sponsored

AVERT™ Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN

AVERT™ Clinical Trial

578
Patients (actual)
39
Sites
Prevention
Purpose
Single blind
Masking
Condition studied Contrast Induced Nephropathy (CIN)
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Roxana Mehran, MD, FACC
Sponsor Osprey Medical, Inc (industry)
Started 2013-12-01 → Primary completion 2015-07-01 → Completed 2015-09-01
Primary outcome
Primary Effectiveness Endpoint
Secondary outcome
Secondary Endpoint 1-
View full study on ClinicalTrials.gov

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 164
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K153141.
DyeVert NG Contrast Modulation System
K161505 · Osprey Medical, Inc. · Aug 2016
DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
K160107 · Merit Medical Systems, Inc. · Jul 2016
DeRoyal Angiography Kits
K152978 · Deroyal Industries, Inc. · Mar 2016
Sterile High-pressure Angiographic Syringes for Single-use
K151960 · Shenzhen Baoan Medical Supplies Co., Ltd. · Jan 2016
330psi Extension Y-Line with Dual Check Valve
K150902 · Coeur, Inc. · Oct 2015
AVERT Contrast Modulation System
K151300 · Osprey Medical, Inc. · Oct 2015