Cleared Special

K112323 - CARDIA-CATH

K112323 is an FDA 510(k) clearance for CARDIA-CATH, manufactured by Millar Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Special 510(k) pathway after a 67-day FDA review.

K112323 · Millar Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
67d
Days
Class 2
Risk

K112323 is an FDA 510(k) clearance for the CARDIA-CATH. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Millar Instruments, Inc. (Houston, US). The FDA issued a Cleared decision on October 18, 2011 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2870 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Millar Instruments, Inc. devices

FDA 510(k) Submission Details - K112323

510(k) Number K112323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2011
Decision Date October 18, 2011
Days to Decision 67 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
58d faster than avg
Panel avg: 125d · This submission: 67d
Pathway characteristics
Modification to existing cleared device.

DXO Device Classification - Class 2, Special Controls

Product Code DXO Transducer, Pressure, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2870
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 - DXO Transducer, Pressure, Catheter Tip

All 55
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K112323.
CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER
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PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER
K080813 · Radi Medical Systems AB · Jul 2008
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