Cleared Traditional

K181817 - transGlideXT Expandable Introducer

K181817 is an FDA 510(k) clearance for transGlideXT Expandable Introducer, manufactured by Transaortic Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K181817 · Transaortic Medical, Inc. · Cardiovascular device
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Mar 2019
Decision
260d
Days
Class 2
Risk

K181817 is an FDA 510(k) clearance for the transGlideXT Expandable Introducer. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Transaortic Medical, Inc. (Morgan Hill, US). The FDA issued a Cleared decision on March 26, 2019 after a review of 260 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Transaortic Medical, Inc. devices

FDA 510(k) Submission Details - K181817

510(k) Number K181817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2018
Decision Date March 26, 2019
Days to Decision 260 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
135d slower than avg
Panel avg: 125d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 598
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K181817.
Guide Sheath
K190644 · Surmodics,Inc. · Apr 2019
M-Y Sheath
K190369 · Ram Medical Innovations, Inc. · Apr 2019
VersaCross Steerable Sheath, VersaCross Transseptal Dilator
K190688 · Baylis Medical Company, Inc. · Apr 2019
Endophys Pressure Sensing Sheath
K190098 · Endophys Holdings, LLC · Mar 2019
iSLEEVE Introducer Set
K190184 · Boston Scientific · Mar 2019
DuraSheath Introducer Sheath System
K181463 · Contract Medical International, GmbH · Dec 2018