INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610— 510(k) K971775

Substantially Equivalent

Cardiac Control Systems, Inc.

FDA 510(k) clearance K971775 for INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610, Substantially Equivalent on 1997-12-29. Applicant: Cardiac Control Systems, Inc..

Clearance details

Applicant: Cardiac Control Systems, Inc.
Product code: Code LDF
Advisory panel: Cardiovascular
Date received: 1997-05-13
Decision date: 1997-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Coast, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LDF

product code LDF

Death: 19
Injury: 188
Malfunction: 694
Other: 1
Total: 902

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.