Cleared Traditional

K153533 - Tearaway Introducer Sheath

K153533 is the FDA 510(k) clearance for Tearaway Introducer Sheath by Galt Medical Corp.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K153533 · Galt Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
209d
Days
Class 2
Risk

K153533 is an FDA 510(k) clearance for the Tearaway Introducer Sheath, MicroSlide Tearaway Introducer. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on July 5, 2016 after a review of 209 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 Galt Medical Corp. devices

Submission Details

510(k) Number K153533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2015
Decision Date July 05, 2016
Days to Decision 209 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 125d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 391
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K153533.
HeartSpan Steerable Sheath Introducer
K170668 · Merit Medical Systems, Inc. · Apr 2017
InTRAkit
K162097 · Medtronic Vascular · Nov 2016
Pinpoint GT Introducer Needle
K162769 · C.R. Bard, Inc. · Nov 2016
Halo One Thin-Walled Guiding Sheath
K161183 · C.R. Bard, Inc. · Jun 2016
GORE DrySeal Flex Introducer Sheath
K160254 · W.L. Gore & Associates, Inc. · May 2016
Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select
K153430 · Cook Incorporated · Mar 2016