Cleared Traditional

K780772 - BJORK-SHILEY CARDIAC HEART VALVE (FDA 510(k) Clearance)

K780772 · Shiley, Inc. · Cardiovascular device
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Sep 1978
Decision
120d
Days
-
Risk

K780772 is an FDA 510(k) clearance for the BJORK-SHILEY CARDIAC HEART VALVE.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 1, 1978 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel. 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.

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Submission Details

510(k) Number K780772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1978
Decision Date September 01, 1978
Days to Decision 120 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -