Cleared Traditional

K924456 - LONG LENGTH PERCUTANEOUS INTRODUCER SET

K924456 is the FDA 510(k) clearance for LONG LENGTH PERCUTANEOUS INTRODUCER SET by Thomas Medical Products, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K924456 · Thomas Medical Products, Inc. · Cardiovascular device
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Mar 1993
Decision
201d
Days
Class 2
Risk

K924456 is an FDA 510(k) clearance for the LONG LENGTH PERCUTANEOUS INTRODUCER SET. 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 March 22, 1993 after a review of 201 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 K924456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1992
Decision Date March 22, 1993
Days to Decision 201 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 125d · This submission: 201d
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 372
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K924456.
BALT INTRODUCER
K925633 · Target Therapeutics · Jun 1993
CORDIS NIHON CATHETER SHEATH INTRODUCER
K931102 · Cordis Corp. · May 1993
ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET
K924607 · Arrow Intl., Inc. · Apr 1993
INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION
K923603 · Kontron Instruments, Inc. · Mar 1993
OVER THE NEEDLE SPLITABLE CATHETER W/FUNNEL LOCATO
K920907 · Teleflexmedical, Inc. · Oct 1992
OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1
K920908 · Teleflexmedical, Inc. · Oct 1992