Cleared Traditional

K170431 - CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170431 · Coeur, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
186d
Days
Class 2
Risk

K170431 is an FDA 510(k) clearance for the CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill.... Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Coeur, Inc. (Lebanon, US). The FDA issued a Cleared decision on August 18, 2017 after a review of 186 days - an extended review cycle.

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 Coeur, Inc. devices

Submission Details

510(k) Number K170431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2017
Decision Date August 18, 2017
Days to Decision 186 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
61d slower than avg
Panel avg: 125d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 206
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K170431.
High Pressure Syringe
K253048 · Shenzhen Maiwei Biotech Co., Ltd. · Apr 2026
Extension tube
K251788 · Zhuhai DR Medical Instruments Co., Ltd. · Mar 2026
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
K252891 · Bayer Medical Care, Inc. · Feb 2026
High Pressure Tubing
K244038 · Shandong Int Medical Instruments Co., Ltd. · Sep 2025
Angiography Injector
K242143 · Shandong Int Medical Instruments Co., Ltd. · Dec 2024
Disposable Syringe (Kit)
K242212 · Nemoto Kyorindo Co., Ltd. · Aug 2024