Cleared Traditional

K122431 - HEARTSPAN STEERABLE INTRODUCER KIT

K122431 is the FDA 510(k) clearance for HEARTSPAN STEERABLE INTRODUCER KIT by Thomas Medical Products, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K122431 · Thomas Medical Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
172d
Days
Class 2
Risk

K122431 is an FDA 510(k) clearance for the HEARTSPAN STEERABLE INTRODUCER KIT. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Thomas Medical Products, Inc. (Malvern, US). The FDA issued a Cleared decision on January 29, 2013 after a review of 172 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 Thomas Medical Products, Inc. devices

Submission Details

510(k) Number K122431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2012
Decision Date January 29, 2013
Days to Decision 172 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
47d slower than avg
Panel avg: 125d · This submission: 172d
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 373
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K122431.
VALVED TEARAWAY INTRODUCER GENERATION II
K124046 · Medical Components, Inc. · Jun 2013
SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING
K123990 · Medtronic Vascular · Apr 2013
EQUAFLOW MULTIVALVE INFUSION CATHETER
K123235 · Cook Incorporated · Feb 2013
DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
K122958 · Oscor, Inc. · Dec 2012
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
K122960 · Oscor, Inc. · Dec 2012
GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING
K121234 · W.L. Gore & Associates, Inc. · Nov 2012