Cleared Traditional

K182660 - GaltTWS

K182660 is an FDA 510(k) clearance for GaltTWS, manufactured by Galt Medical Corp.. The device is a Class 2 Cardiovascular device with product code DRB cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K182660 · Galt Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
247d
Days
Class 2
Risk

K182660 is an FDA 510(k) clearance for the GaltTWS. Classified as Stylet, Catheter (product code DRB), Class II - Special Controls.

Submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on May 30, 2019 after a review of 247 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 Galt Medical Corp. devices

FDA 510(k) Submission Details - K182660

510(k) Number K182660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 125d · This submission: 247d
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 18
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K182660.
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
SPECTRANETICS LLD CS, MODEL 518-039
K043401 · Spectranetics Corp. · Mar 2005