Cleared Traditional

K173399 - Endophys Pressure Sensing Sheath Kit- 8F

K173399 is the FDA 510(k) clearance for Endophys Pressure Sensing Sheath Kit- 8F by Endophys Holdings, LLC. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K173399 · Endophys Holdings, LLC · Cardiovascular device
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Nov 2017
Decision
30d
Days
Class 2
Risk

K173399 is an FDA 510(k) clearance for the Endophys Pressure Sensing Sheath Kit- 8F. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Endophys Holdings, LLC (Dallas, US). The FDA issued a Cleared decision on November 30, 2017 after a review of 30 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 Endophys Holdings, LLC devices

Submission Details

510(k) Number K173399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2017
Decision Date November 30, 2017
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

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