Cleared Special

K132928 - MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE

K132928 is an FDA 510(k) clearance for MEDRAD MARK 7 ARTERION INJECTION SYSTEM..., manufactured by Medrad, Inc. / Bayer Medical Care, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Special 510(k) pathway after a 127-day FDA review.

K132928 · Medrad, Inc. / Bayer Medical Care, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
127d
Days
Class 2
Risk

K132928 is an FDA 510(k) clearance for the MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Medrad, Inc. / Bayer Medical Care, Inc. (Indianola, US). The FDA issued a Cleared decision on January 23, 2014 after a review of 127 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K132928

510(k) Number K132928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2013
Decision Date January 23, 2014
Days to Decision 127 days
Submission Type Special
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
2d slower than avg
Panel avg: 125d · This submission: 127d
Pathway characteristics
Modification to existing cleared device.

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 201
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K132928.
DUAL SHOT ALPHA 7
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K133600 · Coeur, Inc. · Apr 2014
CONTRAST CONSERVATION SYSTEM
K131478 · Osprey Medical, Inc. · Aug 2013
DISPOSABLE 330PSI EXTENSION LINES
K120892 · Coeur, Inc. · Jun 2013
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE
K113133 · Medrad, Inc. · Dec 2011
K132928 · MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE
Download PDF FDA Summary Medrad, Inc. / Bayer …