Cleared Traditional

K861808 - VASCUTEK VASCULAR PROSTHESES

K861808 is the FDA 510(k) clearance for VASCUTEK VASCULAR PROSTHESES by Cobe Laboratories, Inc.. It is a Class 2 Cardiovascular device (product code DSY) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K861808 · Cobe Laboratories, Inc. · Cardiovascular device
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Sep 1986
Decision
129d
Days
Class 2
Risk

K861808 is an FDA 510(k) clearance for the VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Lakewood, US). The FDA issued a Cleared decision on September 15, 1986 after a review of 129 days - within the typical 510(k) review window.

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: 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 Cobe Laboratories, Inc. devices

Submission Details

510(k) Number K861808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1986
Decision Date September 15, 1986
Days to Decision 129 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 125d · This submission: 129d
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 60
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K861808.
PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE)
K893459 · Medtronic Vascular · Sep 1989
GORE-TEX VASCULAR GRAFT
K880167 · W.L. Gore & Associates, Inc. · May 1988
CORONARY ARTERY BYPASS GRAFT (CABG) MARKER
K871110 · Edward Weck, Inc. · Aug 1987
VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES
K853101 · Cobe Laboratories, Inc. · Feb 1986
TETRAFLEX INTEGRALLY SUPPORTED PTFE
K831822 · Shiley, Inc. · Oct 1984
VASCUTEK VASCULAR PROTHESIS VP1200K/50K
K830016 · Pacesetter Systems · Dec 1983