Cleared Traditional

K153533 - Tearaway Introducer Sheath, MicroSlide Tearaway Introducer

K153533 is an FDA 510(k) clearance for Tearaway Introducer Sheath, manufactured by Galt Medical Corp.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K153533

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
Combination Product No
PCCP Authorized No
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.

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 K153533.
HQS Introducer (Model 2064-HQS)
K153494 · Alseal · Aug 2016
GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle
K152913 · Creganna Medical Aslo Business AS Cregganna Tactx Medical · Jul 2016
FlexSeal Introducer Sheath with Hydrophilic Coating
K161659 · Libramedical, Inc. · Jul 2016
Halo One Thin-Walled Guiding Sheath
K161183 · C.R. Bard, Inc. · Jun 2016
Nanostim Introducer Kit
K161102 · St. Jude Medical, Inc. · May 2016
GORE DrySeal Flex Introducer Sheath
K160254 · W.L. Gore & Associates, Inc. · May 2016