Cleared Traditional

K812248 - COOLEY 2 VASCULAR PROSTHESIS STRAIGHT

K812248 is an FDA 510(k) clearance for COOLEY 2 VASCULAR PROSTHESIS STRAIGHT, 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 105-day FDA review.

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

FDA 510(k) Submission Details - K812248

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
Combination Product No
PCCP Authorized No
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.

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 K812248.
MEADOX WOVEN DOUBLE VELOUR
K820696 · Meadox Medicals, Div. Boston Scientific Corp. · Jul 1982
HANCOCK VASCULAR GRAFT
K820600 · Extracorporeal Medical Specialities, Inc. · Jul 1982
FED RINGED-TEX VASCULAR GRAFT
K821158 · W.L. Gore & Associates, Inc. · May 1982
MANUFACTURING PROCESS CHANGE
K811441 · Meadox Medicals, Div. Boston Scientific Corp. · Sep 1981
GORE-TEX VASULAR GRAFT
K811510 · W.L. Gore & Associates, Inc. · Aug 1981
DOUBLE VELOUR GRAFTS
K810845 · Meadox Medicals, Div. Boston Scientific Corp. · May 1981