Cleared Traditional

K141275 - ENDOPHYS PRESSURE SENSING SHEATH KIT

K141275 is an FDA 510(k) clearance for ENDOPHYS PRESSURE SENSING SHEATH KIT, manufactured by Endophys, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K141275 · Endophys, Inc. · Cardiovascular device
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Jan 2015
Decision
236d
Days
Class 2
Risk

K141275 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, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on January 7, 2015 after a review of 236 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 Endophys, Inc. devices

FDA 510(k) Submission Details - K141275

510(k) Number K141275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2014
Decision Date January 07, 2015
Days to Decision 236 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
111d slower than avg
Panel avg: 125d · This submission: 236d
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 K141275.
Chariot Guiding Sheath
K150186 · Boston Scientific Corp · Jun 2015
PINPOINT GT SAFETY INTRODUCER NEEDLE
K142445 · C.R. Bard, Inc. · Apr 2015
Prelude SNAP Splittable Sheath Introducer
K143255 · Merit Medical Systems, Inc. · Apr 2015
FIRSTSTIC N INTRODUCER
K141969 · Argon Medical Devices, Inc. · Dec 2014
NANOSTIM INTRODUCER KIT
K140793 · St. Jude Medical, Inc. · Dec 2014
TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT
K140768 · Lepu Medical Technology (Bejing) Co., Ltd. · Nov 2014