Cleared Traditional

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT (K173773) - FDA 510(k) Clearance

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

K173773 · Bayer Medical Care, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
248d
Days
Class 2
Risk

K173773 is an FDA 510(k) clearance for the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD St.... Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Bayer Medical Care, Inc. (Indianaola, US). The FDA issued a Cleared decision on August 17, 2018 after a review of 248 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 Bayer Medical Care, Inc. devices

Submission Details

510(k) Number K173773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2017
Decision Date August 17, 2018
Days to Decision 248 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
123d slower than avg
Panel avg: 125d · This submission: 248d
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 48
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K173773.
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
K182276 · Bayer Medical Care, Inc. · Nov 2018
DyeVert PLUS EZ Contrast Reduction System
K181936 · Osprey Medical, Inc. · Oct 2018
Sterile High-pressure Angiographic Syringes for Single-use
K182289 · Shenzhen Baoan Medical Supplies Co., Ltd. · Oct 2018
Sterile Disposable Syringes
K172694 · Shenyang Mastech Medical Device Co., Ltd. · Jul 2018
ACISTCVi® Contrast Delivery System
K171646 · Acist Medical Systems, Inc. · Feb 2018
PRESS DUO elite, PRESS DUO elite AG
K173450 · Nemoto Kyorindo Co., Ltd. · Feb 2018