Cleared Traditional

SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS (K993667) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K993667 · Sulzermedica · Cardiovascular device
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Jan 2000
Decision
88d
Days
Class 2
Risk

K993667 is an FDA 510(k) clearance for the SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Sulzermedica (Austin, US). The FDA issued a Cleared decision on January 28, 2000 after a review of 88 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 Sulzermedica devices

Submission Details

510(k) Number K993667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1999
Decision Date January 28, 2000
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
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 58
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K993667.
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
K052964 · Boston Scientific Corp · Jan 2006
LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS
K032900 · Edwards Lifesciences, LLC · Dec 2003
GORE-TEX VASCULAR GRAFT
K013250 · W.L. Gore & Associates, Inc. · Oct 2001
EPTFE RINGED GORE-TEX VASCULAR GRAFT
K991602 · W.L. Gore & Associates, Inc. · Jul 1999
BARD GRAFT SIZER
K961134 · C.R. Bard, Inc. · Jun 1996
DIASTAT VASCULAR ACCESS GRAFT
K955532 · W.L. Gore & Associates, Inc. · Mar 1996