PSA Cable— 510(k) K170815

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K170815 for PSA Cable, Substantially Equivalent on 2017-07-06. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code DTC
Advisory panel: Cardiovascular
Date received: 2017-03-17
Decision date: 2017-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St Paul, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTC

product code DTC

Injury: 136
Malfunction: 3,400
Total: 3,536

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.