Cleared Traditional

K770235 - DEBAKEY VASCULOUR-D PROSTHESES

K770235 is an FDA 510(k) clearance for DEBAKEY VASCULOUR-D PROSTHESES, manufactured by Usci, Div. C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K770235 · Usci, Div. C.R. Bard, Inc. · Cardiovascular device
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Feb 1977
Decision
17d
Days
Class 2
Risk

K770235 is an FDA 510(k) clearance for the DEBAKEY VASCULOUR-D PROSTHESES. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Usci, Div. C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 24, 1977 after a review of 17 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 Usci, Div. C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K770235

510(k) Number K770235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1977
Decision Date February 24, 1977
Days to Decision 17 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 125d · This submission: 17d
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 153
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K770235.
USCI INTRALUMINAL GRAFT W/DACRON TIE
K801156 · C.R. Bard, Inc. · May 1980
USCI SAUVAGE EXS VASCULAR PROSTHESIS
K800149 · C.R. Bard, Inc. · Feb 1980
BJORK-SHILEY PULMONIC GRAFT VALVE
K791828 · Shiley, Inc. · Sep 1979
GRAFT, COOLEY GUIDELINE, STERILE
K760090 · Meadox Medicals, Div. Boston Scientific Corp. · Jul 1976
GRAFT, MICROVEL GUIDELINE, STERILE
K760091 · Meadox Medicals, Div. Boston Scientific Corp. · Jul 1976
GRAFT, COOLEY WOVEN VASCULAR, STERILE
K760092 · Meadox Medicals, Div. Boston Scientific Corp. · Jul 1976