Cleared Traditional

K982419 - HEART-LIFT BALLOON POSITIONER

K982419 is an FDA 510(k) clearance for HEART-LIFT BALLOON POSITIONER, manufactured by Cardiothoracic Systems, Inc.. The device is a Class 1 Cardiovascular device with product code MWS cleared through the Traditional 510(k) pathway after a 184-day FDA review.

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

FDA 510(k) Submission Details - K982419

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.

MWS Device Classification - Class 1, General Controls

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.