Cleared Traditional

CATHETER INTRODUCER (K924562) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924562 · Luther Medical Products, Inc. · Cardiovascular device
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Feb 1993
Decision
169d
Days
Class 2
Risk

K924562 is an FDA 510(k) clearance for the CATHETER INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Luther Medical Products, Inc. (Tustin, US). The FDA issued a Cleared decision on February 25, 1993 after a review of 169 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 Luther Medical Products, Inc. devices

Submission Details

510(k) Number K924562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1992
Decision Date February 25, 1993
Days to Decision 169 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
44d slower than avg
Panel avg: 125d · This submission: 169d
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 229
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K924562.
CORDIS AVANTI CATHETER SHEATH INTRODUCER
K945616 · Cordis Corp. · Mar 1995
CORDIS CATHETER SHEATH INTRODUCER
K932733 · Cordis Corp. · Aug 1993
CORDIS NIHON CATHETER SHEATH INTRODUCER
K931102 · Cordis Corp. · May 1993
CATHETER INTRODUCER
K920528 · Boston Scientific Corp · Aug 1992
GORE TUNNELER, MODIFICATION
K920998 · W.L. Gore & Associates, Inc. · Jun 1992
USCI HEMAQUET XT INTRODUCER
K920251 · C.R. Bard, Inc. · Mar 1992