Cleared Traditional

K872724 - SHEATH/DILATORS

K872724 is the FDA 510(k) clearance for SHEATH/DILATORS by Med-West, Inc.. It is a Class 2 Cardiovascular device (product code DRE) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K872724 · Med-West, Inc. · Cardiovascular device
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Sep 1987
Decision
69d
Days
Class 2
Risk

K872724 is an FDA 510(k) clearance for the SHEATH/DILATORS. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Med-West, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 15, 1987 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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 Med-West, Inc. devices

Submission Details

510(k) Number K872724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1987
Decision Date September 15, 1987
Days to Decision 69 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 125d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 44
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K872724.
VESSEL DILATOR
K904476 · Datascope Corp. · Dec 1990
DAIG VESSEL DILATOR
K894330 · Daig Corp. · Sep 1989
SHILEY FEMORAL CANNULAE INTRODUCER KIT
K881073 · Shiley, Inc. · Jun 1988
URESIL CAROTID ARTERY SIZERS
K871148 · Uresil Corp. · Apr 1987
MODIFICATION OF TISSUE DILATOR
K862288 · Quinton, Inc. · Aug 1986
AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT
K842113 · Mallinckrodt Critical Care · Jul 1984