Cleared Traditional

K112554 - TRANSRADIAL ARTERY ACCESS DEVICES

K112554 is the FDA 510(k) clearance for TRANSRADIAL ARTERY ACCESS DEVICES by Teleflexmedical, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K112554 · Teleflexmedical, Inc. · Cardiovascular device
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Nov 2011
Decision
77d
Days
Class 2
Risk

K112554 is an FDA 510(k) clearance for the TRANSRADIAL ARTERY ACCESS DEVICES. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Reading, US). The FDA issued a Cleared decision on November 18, 2011 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Teleflexmedical, Inc. devices

Submission Details

510(k) Number K112554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2011
Decision Date November 18, 2011
Days to Decision 77 days
Submission Type Traditional
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
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 374
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K112554.
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K120428 · W.L. Gore & Associates, Inc. · Apr 2012
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K111606 · Terumo Medical Corp. · Oct 2011
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K111092 · St Jude Medical · Jun 2011
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K110450 · St Jude Medical · May 2011