CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT— 510(k) K970638

Substantially Equivalent

Cardiothoracic Systems, Inc.

FDA 510(k) clearance K970638 for CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT, Substantially Equivalent on 1997-10-30. Applicant: Cardiothoracic Systems, Inc..

Clearance details

Applicant: Cardiothoracic Systems, Inc.
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 1997-02-20
Decision date: 1997-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

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Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.