Cleared Traditional

COOLEY 2 VASCULAR PROSTHESIS STRAIGHT (K812248) - FDA 510(k) Clearance

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

K812248 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1981
Decision
105d
Days
Class 2
Risk

K812248 is an FDA 510(k) clearance for the COOLEY 2 VASCULAR PROSTHESIS STRAIGHT. 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 November 24, 1981 after a review of 105 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 Meadox Medicals, Div. Boston Scientific Corp. devices

Submission Details

510(k) Number K812248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1981
Decision Date November 24, 1981
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
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 57
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K812248.
IONESCU-SHILEY LOW POROSITY AORTIC GRAFT
K831880 · Shiley, Inc. · Oct 1983
BARD PTFE VASCULAR PROSTHESIS
K821716 · C.R. Bard, Inc. · Aug 1982
FED RINGED-TEX VASCULAR GRAFT
K821158 · W.L. Gore & Associates, Inc. · May 1982
GORE-TEX VASULAR GRAFT
K811510 · W.L. Gore & Associates, Inc. · Aug 1981
IONESCU-SHILEY AORTIC GRAFT VALVE
K803000 · Shiley, Inc. · Feb 1981
GORE-TEX VASCULAR GRAFT
K802095 · W.L. Gore & Associates, Inc. · Oct 1980