Cleared Traditional

K894732 - VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTE...

K894732 is the FDA 510(k) clearance for VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTE... by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DSY) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K894732 · Medtronic Vascular · Cardiovascular device
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Oct 1989
Decision
78d
Days
Class 2
Risk

K894732 is an FDA 510(k) clearance for the VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION). Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on October 12, 1989 after a review of 78 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 Medtronic Vascular devices

Submission Details

510(k) Number K894732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1989
Decision Date October 12, 1989
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
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 95
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K894732.
GORE-TEX(R) STRETCH VASCULAR GRAFT
K903931 · W.L. Gore & Associates, Inc. · Dec 1990
AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT
K901641 · W.L. Gore & Associates, Inc. · Sep 1990
PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC.
K896964 · Medtronic Vascular · Jun 1990
PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE)
K893459 · Medtronic Vascular · Sep 1989
MEADOX INTRA-AORTIC GRAFT
K881283 · Meadox Medicals, Div. Boston Scientific Corp. · May 1988
GORE-TEX VASCULAR GRAFT
K880167 · W.L. Gore & Associates, Inc. · May 1988