Cleared Traditional

GaltTWS

K182660 · Galt Medical Corp. · Cardiovascular
May 2019
Decision
247d
Days
Class 2
Risk

About This 510(k) Submission

K182660 is an FDA 510(k) clearance for the GaltTWS, a Stylet, Catheter (Class II — Special Controls, product code DRB), submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on May 30, 2019, 247 days after receiving the submission on September 25, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1380.

Submission Details

510(k) Number K182660 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2018
Decision Date May 30, 2019
Days to Decision 247 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

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
Liberator Beacon Tip Locking Stylet
K170298 · Cook Incorporated · Oct 2017
LLD EZ
K142116 · Spectranetics, Inc. · Aug 2014
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