Cleared Traditional

HEART-LIFT BALLOON POSITIONER (K982419) - FDA 510(k) Clearance

Class I Cardiovascular device.

K982419 · Cardiothoracic Systems, Inc. · Cardiovascular device
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Jan 1999
Decision
184d
Days
Class 1
Risk

K982419 is an FDA 510(k) clearance for the HEART-LIFT BALLOON POSITIONER. Classified as Stabilizer, Heart (product code MWS), Class I - General Controls.

Submitted by Cardiothoracic Systems, Inc. (Cupertino, US). The FDA issued a Cleared decision on January 13, 1999 after a review of 184 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - 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: 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.

View all Cardiothoracic Systems, Inc. devices

Submission Details

510(k) Number K982419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1998
Decision Date January 13, 1999
Days to Decision 184 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 125d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MWS Stabilizer, Heart
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.