Cleared Traditional

K161659 - FlexSeal Introducer Sheath with Hydroph...

K161659 is an FDA 510(k) clearance for FlexSeal Introducer Sheath with Hydroph..., manufactured by Libramedical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K161659 · Libramedical, Inc. · Cardiovascular device
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Jul 2016
Decision
29d
Days
Class 2
Risk

K161659 is an FDA 510(k) clearance for the FlexSeal Introducer Sheath with Hydrophilic Coating. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Libramedical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 15, 2016 after a review of 29 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Libramedical, Inc. devices

FDA 510(k) Submission Details - K161659

510(k) Number K161659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2016
Decision Date July 15, 2016
Days to Decision 29 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 482
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K161659.
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
Nanostim Introducer Kit
K161102 · St. Jude Medical, Inc. · May 2016
GORE DrySeal Flex Introducer Sheath
K160254 · W.L. Gore & Associates, Inc. · May 2016