VACUUM ASSIST STABILIZER— 510(k) K992833

Name: FDA 510(k) clearance K992833
Creator: U.S. Food and Drug Administration
Published: 1999-11-10

Substantially Equivalent

Cardio Thoracic Systems

FDA 510(k) clearance K992833 for VACUUM ASSIST STABILIZER, Substantially Equivalent on 1999-11-10. Applicant: Cardio Thoracic Systems. Device class: 1.

Clearance details

Applicant: Cardio Thoracic Systems
Product code: Code MWS
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 1999-08-23
Decision date: 1999-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

Download summary PDF View on FDA.gov ↗

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K982419 — HEART-LIFT BALLOON POSITIONER1999-01-13

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Adverse events under product code MWS

product code MWS

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.