Cleared Traditional

K990713 - SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1

K990713 is an FDA 510(k) clearance for SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, 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 232-day FDA review.

K990713 · Spectranetics Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
232d
Days
Class 2
Risk

K990713 is an FDA 510(k) clearance for the SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER. 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 October 22, 1999 after a review of 232 days - an extended review 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: 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 - K990713

510(k) Number K990713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1999
Decision Date October 22, 1999
Days to Decision 232 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
107d slower than avg
Panel avg: 125d · This submission: 232d
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 K990713.
STYLET KIT, MODELS 6254,6282,6293
K003535 · Medtronic Vascular · Feb 2001
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