LLD EZ

Stylet, Catheter

SPECTRANETICS, INC.

The following data is part of a premarket notification filed by Spectranetics, Inc. with the FDA for Lld Ez.

Pre-market Notification Details

Device IDK142116
510k NumberK142116
Device Name:LLD EZ
ClassificationStylet, Catheter
Applicant SPECTRANETICS, INC. 9965 Federal Drive Colorado Springs,  CO  80921
ContactPharoah Garma
CorrespondentPharoah Garma
SPECTRANETICS, INC. 9965 Federal Drive Colorado Springs,  CO  80921
Product CodeDRB  
CFR Regulation Number870.1380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-04
Decision Date2014-08-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20813132023076 K142116 000
M204518067AB0 K142116 000
M204518062AA0 K142116 000
00813132020835 K142116 000
M2045180670 K142116 000
M2045180621 K142116 000

Trademark Results [LLD EZ]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LLD EZ
LLD EZ
77309793 3562200 Live/Registered
The Spectranetics Corporation
2007-10-22

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