Cleared Traditional

K862739 - INTERVASCULAR OCHSNER MICRON VASCULAR P...

K862739 is the FDA 510(k) clearance for INTERVASCULAR OCHSNER MICRON VASCULAR P... by Intervascular, Inc.. It is a Class 2 Cardiovascular device (product code DSY) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K862739 · Intervascular, Inc. · Cardiovascular device
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Aug 1986
Decision
31d
Days
Class 2
Risk

K862739 is an FDA 510(k) clearance for the INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESES. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Intervascular, Inc. (Clearwater, US). The FDA issued a Cleared decision on August 21, 1986 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - 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 Intervascular, Inc. devices

Submission Details

510(k) Number K862739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1986
Decision Date August 21, 1986
Days to Decision 31 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 125d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
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 - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 107
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K862739.
GORE-TEX VASCULAR GRAFT
K880167 · W.L. Gore & Associates, Inc. · May 1988
CORONARY ARTERY BYPASS GRAFT (CABG) MARKER
K871110 · Edward Weck, Inc. · Aug 1987
VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN
K861808 · Cobe Laboratories, Inc. · Sep 1986
MEADOS INTRAORTIC GRAFT
K841596 · Meadox Medicals, Div. Boston Scientific Corp. · May 1986
MEADOX MEDICALS INC. GRAFT SIZER
K854431 · Meadox Medicals, Div. Boston Scientific Corp. · May 1986
VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES
K853101 · Cobe Laboratories, Inc. · Feb 1986