Cleared Traditional

K070798 - ADAPTERS FOR CT

K070798 is an FDA 510(k) clearance for ADAPTERS FOR CT, manufactured by Coeur, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K070798 · Coeur, Inc. · Cardiovascular device
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Oct 2007
Decision
195d
Days
Class 2
Risk

K070798 is an FDA 510(k) clearance for the ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS. 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 October 4, 2007 after a review of 195 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

FDA 510(k) Submission Details - K070798

510(k) Number K070798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2007
Decision Date October 04, 2007
Days to Decision 195 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
70d slower than avg
Panel avg: 125d · This submission: 195d
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 119
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K070798.
MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE
K083523 · Merit Medical Systems, Inc. · Feb 2009
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC
K082905 · Medrad, Inc. · Jan 2009
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T
K072886 · Medrad, Inc. · Dec 2007
CKIS-004A INJECTOR SYNCHRONIZATION OPTION
K061976 · Toshiba America Medical Systems, In.C · Sep 2006
MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
K050456 · Medrad, Inc. · Jun 2005
MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM
K042784 · Medrad, Inc. · Dec 2004