Cleared Special

K180620 - Endophys Pressure Sensing Sheath Kit

K180620 is an FDA 510(k) clearance for Endophys Pressure Sensing Sheath Kit, manufactured by Endophys Holdings, LLC. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 217-day FDA review.

K180620 · Endophys Holdings, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
217d
Days
Class 2
Risk

K180620 is an FDA 510(k) clearance for the Endophys Pressure Sensing Sheath Kit. 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 October 12, 2018 after a review of 217 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K180620

510(k) Number K180620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2018
Decision Date October 12, 2018
Days to Decision 217 days
Submission Type Special
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
92d slower than avg
Panel avg: 125d · This submission: 217d
Pathway characteristics
Modification to existing cleared device.

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

Sachs & Associates, Inc.
Gregory W. Sachs

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 705
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K180620.
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TSP Crosser Transseptal Access System
K181088 · Transseptal Solutions , Ltd. · Sep 2018
The CVC WAND Safety Introducer with Valved Peelable Sheath
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RAIN Sheath Transradial
K181592 · Cordis Corporation · Aug 2018
K180620 · Endophys Pressure Sensing Sheath Kit
Download PDF FDA Summary Endophys Holdings, LLC