Cleared Traditional

K810845 - DOUBLE VELOUR GRAFTS

K810845 is an FDA 510(k) clearance for DOUBLE VELOUR GRAFTS, manufactured by Meadox Medicals, Div. Boston Scientific Corp.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K810845 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular device
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May 1981
Decision
42d
Days
Class 2
Risk

K810845 is an FDA 510(k) clearance for the DOUBLE VELOUR GRAFTS. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Mchenry, US). The FDA issued a Cleared decision on May 8, 1981 after a review of 42 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 Meadox Medicals, Div. Boston Scientific Corp. devices

FDA 510(k) Submission Details - K810845

510(k) Number K810845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1981
Decision Date May 08, 1981
Days to Decision 42 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
83d faster than avg
Panel avg: 125d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSY Device Classification - Class 2, Special Controls

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 106
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K810845.
COOLEY 2 VASCULAR PROSTHESIS STRAIGHT
K812248 · Meadox Medicals, Div. Boston Scientific Corp. · Nov 1981
MANUFACTURING PROCESS CHANGE
K811441 · Meadox Medicals, Div. Boston Scientific Corp. · Sep 1981
GORE-TEX VASULAR GRAFT
K811510 · W.L. Gore & Associates, Inc. · Aug 1981
MEADOX SZILAGYI GRAFT
K810376 · Meadox Medicals, Div. Boston Scientific Corp. · Mar 1981
IONESCU-SHILEY AORTIC GRAFT VALVE
K803000 · Shiley, Inc. · Feb 1981
GORE-TEX VASCULAR GRAFT
K802095 · W.L. Gore & Associates, Inc. · Oct 1980