Cleared Traditional

K790425 - IONESCU-SHILEY COMPOSITE CONDUIT-PULMONI (FDA 510(k) Clearance)

K790425 · Shiley, Inc. · Cardiovascular device
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Mar 1979
Decision
26d
Days
-
Risk

K790425 is an FDA 510(k) clearance for the IONESCU-SHILEY COMPOSITE CONDUIT-PULMONI.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 28, 1979 after a review of 26 days - a notably fast clearance cycle.

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: 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

Submission Details

510(k) Number K790425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1979
Decision Date March 28, 1979
Days to Decision 26 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -