Cleared Special

LLD EZ

K142116 · Spectranetics, Inc. · Cardiovascular
Aug 2014
Decision
8d
Days
Class 2
Risk

About This 510(k) Submission

K142116 is an FDA 510(k) clearance for the LLD EZ, a Stylet, Catheter (Class II — Special Controls, product code DRB), submitted by Spectranetics, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on August 12, 2014, 8 days after receiving the submission on August 4, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1380.

Submission Details

510(k) Number K142116 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2014
Decision Date August 12, 2014
Days to Decision 8 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DRB — Stylet, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1380

Similar Devices — DRB Stylet, Catheter

All 27
Arrow Stiffening Stylet
K220280 · Arrow International, LLC (A subsidiary of Teleflex, Inc.) · Aug 2022
Biotronik Stylets
K191469 · Biotronik, Inc. · Aug 2019
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
MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151
K080924 · St. Jude Medical, Cardiac Rhythm Management Divisi · Apr 2008

More from Spectranetics, Inc.

View all
TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)
K223472 · DRE · Dec 2022
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K222837 · MCW · Dec 2022
TightRail Guardian Motorized Dilator Sheath
K212784 · DRE · Aug 2022
CavaClear Laser Sheath
DEN210024 · QRJ · Dec 2021
Bridge Occlusion Balloon
K203540 · MJN · Dec 2020