Cleared Traditional

K791828 - BJORK-SHILEY PULMONIC GRAFT VALVE

K791828 is an FDA 510(k) clearance for BJORK-SHILEY PULMONIC GRAFT VALVE, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K791828 · Shiley, Inc. · Cardiovascular device
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Sep 1979
Decision
10d
Days
Class 2
Risk

K791828 is an FDA 510(k) clearance for the BJORK-SHILEY PULMONIC GRAFT VALVE. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1979 after a review of 10 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K791828

510(k) Number K791828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1979
Decision Date September 27, 1979
Days to Decision 10 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
115d faster than avg
Panel avg: 125d · This submission: 10d
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 125
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K791828.
VASCULAR GRAFT PROSTH. OF EXP. MICRO.
K801621 · Impra, Inc. · Sep 1980
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
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