Cleared Traditional

K002534 - EUPALAMUS DEFLECTABLE STYLET, MODEL 01545

K002534 is an FDA 510(k) clearance for EUPALAMUS DEFLECTABLE STYLET, manufactured by Eupalamus, LLC. The device is a Class 2 Cardiovascular device with product code DRB cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K002534 · Eupalamus, LLC · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2000
Decision
63d
Days
Class 2
Risk

K002534 is an FDA 510(k) clearance for the EUPALAMUS DEFLECTABLE STYLET, MODEL 01545. Classified as Stylet, Catheter (product code DRB), Class II - Special Controls.

Submitted by Eupalamus, LLC (Brentwood, US). The FDA issued a Cleared decision on October 18, 2000 after a review of 63 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 Eupalamus, LLC devices

FDA 510(k) Submission Details - K002534

510(k) Number K002534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2000
Decision Date October 18, 2000
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRB Device Classification - Class 2, Special Controls

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 19
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K002534.
SPECTRANETICS LLD CS, MODEL 518-039
K043401 · Spectranetics Corp. · Mar 2005
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
K010906 · Medtronic Vascular · Apr 2001
STYLET KIT, MODELS 6254,6282,6293
K003535 · Medtronic Vascular · Feb 2001
PLACER MODEL 6232 STEERABLE STYLET
K000955 · Medtronic Vascular · Jun 2000
TFX MEDICAL STYLET CATHETER
K992664 · Tfx Medical Group · Apr 2000
ENSTYLET MODELS EC0010, EC0020
K993376 · Endocardial Solutions, Inc. · Jan 2000