Cleared Traditional

K072696 - ANT ANGIOGRAPHIC SYRINGES

K072696 is the FDA 510(k) clearance for ANT ANGIOGRAPHIC SYRINGES by Shenzhen Ant Hi-Tech Industrial Co., Ltd.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K072696 · Shenzhen Ant Hi-Tech Industrial Co., Ltd. · Cardiovascular device
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May 2008
Decision
221d
Days
Class 2
Risk

K072696 is an FDA 510(k) clearance for the ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,.... Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Shenzhen Ant Hi-Tech Industrial Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on May 2, 2008 after a review of 221 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 Shenzhen Ant Hi-Tech Industrial Co., Ltd. devices

Submission Details

510(k) Number K072696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2007
Decision Date May 02, 2008
Days to Decision 221 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
96d slower than avg
Panel avg: 125d · This submission: 221d
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 102
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K072696.
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
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