CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD— 510(k) K864601

Substantially Equivalent

Cardiac Control Systems, Inc.

FDA 510(k) clearance K864601 for CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD, Substantially Equivalent on 1987-01-06. Applicant: Cardiac Control Systems, Inc..

Clearance details

Applicant: Cardiac Control Systems, Inc.
Product code: Code DTB
Advisory panel: Cardiovascular
Date received: 1986-11-24
Decision date: 1987-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Coast, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTB

product code DTB

Death: 1,491
Injury: 67,311
Malfunction: 79,368
Other: 10
Total: 148,180

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.