Cleared Traditional

K173399 - Endophys Pressure Sensing Sheath Kit- 8F

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

K173399 · Endophys Holdings, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K173399

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DYB Introducer, Catheter

All 598
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K173399.
Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design
K171275 · Cook Incorporated · Dec 2017
Sentrant Introducer Sheath with Hydrophilic Coating
K171866 · Medtronic Vascular, Inc. · Dec 2017
Peel-Away Introducer Set
K173685 · Cook Incorporated · Dec 2017
Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath
K172995 · Terumo Medical Corporation · Nov 2017
Performer Introducer
K173068 · Cook Incorporated · Nov 2017
D'Vill Introducer
K171206 · NuMED, Inc. · Oct 2017