Cleared Special

K112398 - TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT

K112398 is an FDA 510(k) clearance for TRIV(TM) VALVED TEARAWAY INTRODUCER, manufactured by Galt Medical. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 237-day FDA review.

K112398 · Galt Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
237d
Days
Class 2
Risk

K112398 is an FDA 510(k) clearance for the TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH.... Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Galt Medical (Buford, US). The FDA issued a Cleared decision on April 12, 2012 after a review of 237 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 - K112398

510(k) Number K112398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2011
Decision Date April 12, 2012
Days to Decision 237 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 125d · This submission: 237d
Pathway characteristics
Modification to existing cleared device.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 667
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K112398 · TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT
Download PDF FDA Summary Galt Medical