Cleared Traditional

K912050 - NOVOSTE VESSEL DILATER

K912050 is an FDA 510(k) clearance for NOVOSTE VESSEL DILATER, manufactured by Novaste Corp.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K912050 · Novaste Corp. · Cardiovascular device
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Oct 1991
Decision
153d
Days
Class 2
Risk

K912050 is an FDA 510(k) clearance for the NOVOSTE VESSEL DILATER. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Novaste Corp. (Aguadilla, US). The FDA issued a Cleared decision on October 9, 1991 after a review of 153 days - an extended review 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: 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 Novaste Corp. devices

FDA 510(k) Submission Details - K912050

510(k) Number K912050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1991
Decision Date October 09, 1991
Days to Decision 153 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 125d · This submission: 153d
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 86
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K912050.
PERCUGLIDE
K960917 · Scientific Device Manufacturer, LLC · Jul 1996
WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI)
K914555 · Med Institute, Inc. · Jan 1992
VESSEL DILATOR
K913027 · Deseret Medical, Inc. · Nov 1991
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