REMOVABLE PATIENT LEADS ECG CABLE— 510(k) K132253

Substantially Equivalent

Boston Scientific

FDA 510(k) clearance K132253 for REMOVABLE PATIENT LEADS ECG CABLE, Substantially Equivalent on 2013-12-16. Applicant: Boston Scientific.

Clearance details

Applicant: Boston Scientific
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2013-07-19
Decision date: 2013-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St Paul, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.