Cleared Traditional

K953396 - CARDIOVIT AT-1C, AT-2C (FDA 510(k) Clearance)

K953396 · Schiller America, Inc. · Cardiovascular device
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Dec 1995
Decision
152d
Days
-
Risk

K953396 is an FDA 510(k) clearance for the CARDIOVIT AT-1C, AT-2C.

Submitted by Schiller America, Inc. (Tustin, US). The FDA issued a Cleared decision on December 19, 1995 after a review of 152 days - an extended review 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: 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 K953396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1995
Decision Date December 19, 1995
Days to Decision 152 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 125d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -