Cleared Traditional

K043401 - SPECTRANETICS LLD CS

K043401 is an FDA 510(k) clearance for SPECTRANETICS LLD CS, manufactured by Spectranetics Corp.. The device is a Class 2 Cardiovascular device with product code DRB cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K043401 · Spectranetics Corp. · Cardiovascular device
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Mar 2005
Decision
96d
Days
Class 2
Risk

K043401 is an FDA 510(k) clearance for the SPECTRANETICS LLD CS, MODEL 518-039. Classified as Stylet, Catheter (product code DRB), Class II - Special Controls.

Submitted by Spectranetics Corp. (Colorado Springs, US). The FDA issued a Cleared decision on March 16, 2005 after a review of 96 days - within the typical 510(k) review window.

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: 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 Spectranetics Corp. devices

FDA 510(k) Submission Details - K043401

510(k) Number K043401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2004
Decision Date March 16, 2005
Days to Decision 96 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 125d · This submission: 96d
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 15
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K043401.
GaltTWS
K182660 · Galt Medical Corp. · May 2019
Liberator Beacon Tip Locking Stylet
K170298 · Cook Incorporated · Oct 2017
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
K090163 · St Jude Medical · Apr 2009
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