Cleared Traditional

K913543 - THORACIC CATHETER STYLET

K913543 is the FDA 510(k) clearance for THORACIC CATHETER STYLET by Intl. Medical Devices , Ltd.. It is a Class 2 Cardiovascular device (product code DRB) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K913543 · Intl. Medical Devices , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
56d
Days
Class 2
Risk

K913543 is an FDA 510(k) clearance for the THORACIC CATHETER STYLET. Classified as Stylet, Catheter (product code DRB), Class II - Special Controls.

Submitted by Intl. Medical Devices , Ltd. (Los Angeles, US). The FDA issued a Cleared decision on October 4, 1991 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1380 - 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.

View all Intl. Medical Devices , Ltd. devices

Submission Details

510(k) Number K913543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1991
Decision Date October 04, 1991
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRB Stylet, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1380
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 - DRB Stylet, Catheter

All 14
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K913543.
PLACER MODEL 6232 STEERABLE STYLET
K000955 · Medtronic Vascular · Jun 2000
LEAD STYLET,MODELS 6505,6506,6507,6508
K992863 · Guidant Corp. · Nov 1999
TARGET THERAPEUTICS RADIOPAQUE STYLET
K914001 · Target Therapeutics · Nov 1991
LEAD STYLET
K905674 · Cardiac Pacemakers, Inc. · Jan 1991
TUNNELING STYLET
K882097 · Quinton, Inc. · Jul 1988
STIFF STYLETS
K802076 · Cardiac Pacemakers, Inc. · Sep 1980