Cleared Traditional

K123974 - PERCUTANEOUS INTRODUCER KIT

K123974 is an FDA 510(k) clearance for PERCUTANEOUS INTRODUCER KIT, manufactured by Teleflex, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K123974 · Teleflex, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
57d
Days
Class 2
Risk

K123974 is an FDA 510(k) clearance for the PERCUTANEOUS INTRODUCER KIT. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Teleflex, Inc. (Jaffrey, US). The FDA issued a Cleared decision on February 21, 2013 after a review of 57 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.

FDA 510(k) Submission Details - K123974

510(k) Number K123974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2012
Decision Date February 21, 2013
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 662
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K123974.
SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING
K123990 · Medtronic Vascular · Apr 2013
MICROSLIDER TEARAWAY INTRODUCER SET
K123430 · Galt Medical Corp. · Apr 2013
AXERA 2 ACCESS SYSTEM
K123618 · Arstasis, Inc. · Mar 2013
EQUAFLOW MULTIVALVE INFUSION CATHETER
K123235 · Cook Incorporated · Feb 2013
HEARTSPAN STEERABLE INTRODUCER KIT
K122431 · Thomas Medical Products, Inc. · Jan 2013
AXERA 2 ACCESS SYSTEM MODEL AXE200
K123135 · Arstasis, Inc. · Jan 2013