Cleared Traditional

K113849 - HQS INTRODUCER

K113849 is an FDA 510(k) clearance for HQS INTRODUCER, manufactured by Alseal. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K113849 · Alseal · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
215d
Days
Class 2
Risk

K113849 is an FDA 510(k) clearance for the HQS INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Alseal (Besancon, FR). The FDA issued a Cleared decision on July 31, 2012 after a review of 215 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Alseal devices

FDA 510(k) Submission Details - K113849

510(k) Number K113849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2011
Decision Date July 31, 2012
Days to Decision 215 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 125d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 482
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K113849.
EDWARDS PERCUTANEOUS SHEATH INTRODUCER
K121185 · Edwards Lifesciences, LLC · Aug 2012
PRELUDE 7F SHORT SHEATH INTRODUCER
K122190 · Merit Medical Systems, Inc. · Aug 2012
CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS
K120158 · Thomas Medical Products, Inc. · Aug 2012
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
K120459 · Oscor, Inc. · Jun 2012
GORE DRYSEAL SHEATH
K120428 · W.L. Gore & Associates, Inc. · Apr 2012
SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS
K112407 · Smiths Medical MD, Inc. · Feb 2012