Cleared Traditional

K913027 - VESSEL DILATOR

K913027 is an FDA 510(k) clearance for VESSEL DILATOR, manufactured by Deseret Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K913027 · Deseret Medical, Inc. · Cardiovascular device
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Nov 1991
Decision
141d
Days
Class 2
Risk

K913027 is an FDA 510(k) clearance for the VESSEL DILATOR. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Deseret Medical, Inc. (Sandy, US). The FDA issued a Cleared decision on November 27, 1991 after a review of 141 days - within the typical 510(k) review window.

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: 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 Deseret Medical, Inc. devices

FDA 510(k) Submission Details - K913027

510(k) Number K913027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1991
Decision Date November 27, 1991
Days to Decision 141 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
16d slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRE Device Classification - Class 2, Special Controls

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 84
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K913027.
VESSEL DILATOR
K963388 · Maxxim Medical · Mar 1997
PERCUGLIDE
K960917 · Scientific Device Manufacturer, LLC · Jul 1996
WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI)
K914555 · Med Institute, Inc. · Jan 1992
VESSEL DILATOR
K904476 · Datascope Corp. · Dec 1990
MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY
K901815 · Pioneering Technologies, Inc. · Jul 1990
SOLOSTICK (AMPLATZ DILATOR NEEDLE)
K896096 · Microvena Corp. · Apr 1990