Cleared Traditional

K082905 - MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC

K082905 is an FDA 510(k) clearance for MEDRAD STELLANT CT INJECTOR SYSTEM WITH..., manufactured by Medrad, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K082905 · Medrad, Inc. · Cardiovascular device
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Jan 2009
Decision
104d
Days
Class 2
Risk

K082905 is an FDA 510(k) clearance for the MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on January 12, 2009 after a review of 104 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 Medrad, Inc. devices

FDA 510(k) Submission Details - K082905

510(k) Number K082905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2008
Decision Date January 12, 2009
Days to Decision 104 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
21d faster than avg
Panel avg: 125d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 169
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K082905.
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE
K112086 · Medrad, Inc. · Oct 2011
MEDLINE ANGIOGRAPHIC CONTROL SYRINGE
K093830 · Medline Industries, Inc. · Mar 2011
MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE
K083523 · Merit Medical Systems, Inc. · Feb 2009
OPTISTAR ELITE INJECTION SYSTEM
K073592 · Mallinckrodt Inc., Liebel-Flarsheim Business · May 2008
ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301
K072696 · Shenzhen Ant Hi-Tech Industrial Co., Ltd. · May 2008
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T
K072886 · Medrad, Inc. · Dec 2007